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\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
","study.pubmedId":11872997,"study.embaseId":null,"study.croIdentifier":"University of California, San Francisco","study.croInformation":"University of California, San Francisco","study.dateStart":null,"study.dateEnd":null,"study.internalComment":null,"study.status":"published","study.compoundId":null,"study.naturalProductUid":"NP-0162af79-839e-40e2-af47-361c659061e9","study.naturalProductSampleId":null,"study.studySourceTypeId":1,"study.naturalProduct.uid":"NP-0162af79-839e-40e2-af47-361c659061e9","study.naturalProduct.binomial":"Cannabis 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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
","study.pubmedId":11872997,"study.embaseId":null,"study.croIdentifier":"University of California, San Francisco","study.croInformation":"University of California, San Francisco","study.dateStart":null,"study.dateEnd":null,"study.internalComment":null,"study.status":"published","study.compoundId":null,"study.naturalProductUid":"NP-0162af79-839e-40e2-af47-361c659061e9","study.naturalProductSampleId":null,"study.studySourceTypeId":1,"study.naturalProduct.uid":"NP-0162af79-839e-40e2-af47-361c659061e9","study.naturalProduct.binomial":"Cannabis 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demographics reported include subjects not taking NFV.
Nine subjects' ethnicity is reported as \"mixed/other\" and is not further specified.
Age (years):
\r\n\r\n- < 40: 18 (29%)
\r\n- 40 - 49: 33 (53%)
\r\n- ≥ 50: 11 (18%)
\r\n
","experimentAnswers.answerId":null,"experimentAnswers.experimentId":303,"experimentAnswers.questionId":107,"experimentAnswers.question.id":107,"experimentAnswers.question.text":"Population additional information","experimentAnswers.question.required":false,"experimentAnswers.question.maxAnswers":null,"experimentAnswers.question.type":"TEXT","experimentAnswers.question.conceptId":null,"experimentAnswers.question.answers.id":null,"experimentAnswers.question.answers.text":null,"experimentAnswers.question.answers.sortOrder":null,"experimentAnswers.question.answers.conceptId":null,"experimentAnswers.question.answers.questionId":null,"experimentAnswers.answer.id":null,"experimentAnswers.answer.text":null,"experimentAnswers.answer.sortOrder":null,"experimentAnswers.answer.conceptId":null,"experimentAnswers.answer.questionId":null},{"id":303,"uid":"NPDI-J5A-Vg","name":"NFV+THC PK at Baseline and Day 14","overallEffect":0,"isControlData":false,"isIc50Shift":false,"croCutoff":null,"croIdentifier":null,"comment":"NFV = nelfinavir
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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PK at Baseline and Day 14","overallEffect":0,"isControlData":false,"isIc50Shift":false,"croCutoff":null,"croIdentifier":null,"comment":"NFV = nelfinavir
THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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than one race","experimentAnswers.answer.sortOrder":null,"experimentAnswers.answer.conceptId":null,"experimentAnswers.answer.questionId":103},{"id":303,"uid":"NPDI-J5A-Vg","name":"NFV+THC PK at Baseline and Day 14","overallEffect":0,"isControlData":false,"isIc50Shift":false,"croCutoff":null,"croIdentifier":null,"comment":"NFV = nelfinavir
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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or African American","experimentAnswers.answer.sortOrder":null,"experimentAnswers.answer.conceptId":null,"experimentAnswers.answer.questionId":103},{"id":303,"uid":"NPDI-J5A-Vg","name":"NFV+THC PK at Baseline and Day 14","overallEffect":0,"isControlData":false,"isIc50Shift":false,"croCutoff":null,"croIdentifier":null,"comment":"NFV = nelfinavir
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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than one race","experimentAnswers.answer.sortOrder":null,"experimentAnswers.answer.conceptId":null,"experimentAnswers.answer.questionId":103},{"id":303,"uid":"NPDI-J5A-Vg","name":"NFV+THC PK at Baseline and Day 14","overallEffect":0,"isControlData":false,"isIc50Shift":false,"croCutoff":null,"croIdentifier":null,"comment":"NFV = nelfinavir
THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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THC = delta-9-THC","experimentalConditionsComment":null,"resultsComment":"Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).","internalComment":null,"objectCompoundId":131,"objectMetaboliteCompoundId":null,"precipitantCompoundId":118,"cytochromeB5Id":null,"studyId":74,"experimentTypeId":9,"testSystemId":null,"ic50ShiftExperimentId":null,"controlDataExperimentId":null,"controlDataForExperimentId":null,"naturalProductSampleId":null,"experimentType.id":9,"experimentType.name":"In Vivo Interaction","experimentType.isInVitro":false,"experimentType.isTransporter":false,"experimentType.isEnzyme":false,"experimentType.purl":"http://purl.obolibrary.org/obo/DIDEO_00000071","objectCompound.id":131,"objectCompound.name":"nelfinavir","objectCompound.unii":null,"objectCompound.inChIKey":"QAGYKUNXZHXKMR-HKWSIXNMSA-N","objectCompound.publicDescription":null,"objectCompound.internalComment":null,"objectCompound.conceptId":null,"objectCompound.enantiomerOfId":null,"objectCompound.concept.conceptId":null,"objectCompound.concept.conceptName":null,"objectCompound.concept.domainId":null,"objectCompound.concept.vocabularyId":null,"objectCompound.concept.conceptClassId":null,"objectCompound.concept.standardConcept":null,"objectCompound.concept.conceptCode":null,"objectCompound.concept.validStartDate":null,"objectCompound.concept.validEndDate":null,"objectCompound.concept.invalid_reason":null,"precipitantCompound.id":118,"precipitantCompound.name":"delta-9-tetrahydrocannabinol","precipitantCompound.unii":null,"precipitantCompound.inChIKey":"CYQFCXCEBYINGO-UHFFFAOYSA-N","precipitantCompound.publicDescription":null,"precipitantCompound.internalComment":null,"precipitantCompound.conceptId":null,"precipitantCompound.enantiomerOfId":null,"precipitantCompound.concept.conceptId":null,"precipitantCompound.concept.conceptName":null,"precipitantCompound.concept.domainId":null,"precipitantCompound.concept.vocabularyId":null,"precipitantCompound.concept.conceptClassId":null,"precipitantCompound.concept.standardConcept":null,"precipitantCompound.concept.conceptCode":null,"precipitantCompound.concept.validStartDate":null,"precipitantCompound.concept.validEndDate":null,"precipitantCompound.concept.invalid_reason":null,"objectMetaboliteCompound.id":null,"objectMetaboliteCompound.name":null,"objectMetaboliteCompound.unii":null,"objectMetaboliteCompound.inChIKey":null,"objectMetaboliteCompound.publicDescription":null,"objectMetaboliteCompound.internalComment":null,"objectMetaboliteCompound.conceptId":null,"objectMetaboliteCompound.enantiomerOfId":null,"objectMetaboliteCompound.concept.conceptId":null,"objectMetaboliteCompound.concept.conceptName":null,"objectMetaboliteCompound.concept.domainId":null,"objectMetaboliteCompound.concept.vocabularyId":null,"objectMetaboliteCompound.concept.conceptClassId":null,"objectMetaboliteCompound.concept.standardConcept":null,"objectMetaboliteCompound.concept.conceptCode":null,"objectMetaboliteCompound.concept.validStartDate":null,"objectMetaboliteCompound.concept.validEndDate":null,"objectMetaboliteCompound.concept.invalid_reason":null,"enzymes.id":null,"enzymes.name":null,"enzymes.conceptId":null,"enzymes.experiment_enzyme_xref.enzymeId":null,"enzymes.experiment_enzyme_xref.experimentId":null,"transporters.id":null,"transporters.name":null,"transporters.conceptId":null,"transporters.experiment_transporter_xref.experimentId":null,"transporters.experiment_transporter_xref.transporterId":null,"quantifiedMetabolites.id":null,"quantifiedMetabolites.name":null,"quantifiedMetabolites.unii":null,"quantifiedMetabolites.inChIKey":null,"quantifiedMetabolites.publicDescription":null,"quantifiedMetabolites.internalComment":null,"quantifiedMetabolites.conceptId":null,"quantifiedMetabolites.enantiomerOfId":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.com":null,"quantifiedMetabolites.experiment_quantified_metabolite_xref.exp":null,"study.id":74,"study.uid":"NPDI-qOTUkQ","study.name":"The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir","study.napdiIdentifier":"PMID: 11872997","study.overallSummary":"\r\n
\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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\r\n
\r\n
Background and objectives: The use of cannabinoids for appetite stimulation and the management of wasting and antiretroviral side-effects has become a common practice in the care of HIV-infected individuals. We present pharmacokinetic data from a randomized placebo-controlled study designed to evaluate the metabolic effects of smoked marijuana and dronabinol in HIV-infected patients receiving indinavir (IDV) or nelfinavir (NFV).
\r\n
Methods: Subjects on stable regimens containing IDV 800 mg every 8 h (n = 28) or NFV 750 mg three time a day (n = 34) were randomized to one of three treatment arms: 3.95% THC marijuana cigarettes, dronabinol 2.5 mg capsules or placebo capsules administered three times daily. Serial blood sampling was performed at baseline and on day 14 of treatment. The changes in NFV and IDV pharmacokinetics were measured as the median percentage change from baseline.
\r\n
Results: At day 14, the 8-h area under the curve (AUC8) changed by 10.2% (P 0.15), maximum concentration (Cmax) by 17.4% (P 0.46), and minimum concentration (Cmin) by 12.2% (P 0.28) for patients in the NFV marijuana arm (n 11). Similar decreases had occurred by day 14 among patients in the IDV marijuana arm (n 9): AUC8 had changed by 14.5% (P 0.074), Cmax by 14.1% (P 0.039), and Cmin by 33.7% (P 0.65).
\r\n
Conclusion: Despite a statistically significant decrease in Cmax of IDV in the marijuana arm, the magnitude of changes in IDV and NFV pharmacokinetic parameters in the marijuana arm are likely to have no short-term clinical consequence. The use of marijuana or dronabinol is unlikely to impact antiretroviral efficacy.
\r\n
\r\n
\r\n
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