IDV+THC PK at Baseline and Day 14 CSV JSON

In Vivo Interaction Study

IDV+THC PK at Baseline and Day 14

No Effect (based on bioequivalence limits) was detected.

indinavir

IDV = indiavir
THC = delta-9-THC
Baseline = control
Day 14 = test

Results

Table 2. Cmax % Change reported as -14.1 (-58 to 7), p = 0.039; AUC0-8 % change reported as -14 (-66 to 44)

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.

Sample Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Inclusion criteria: at least 18 years old, have documented HIV infection, and be on a stable antire- troviral treatment regimen that included either IDV or NFV as the sole PI in addition to nucleoside and/or non-nucleoside reverse transcriptase inhibitors, for at least 8 weeks prior to enrollment. Subjects were also required to have a stable viral load, de®ned as less than a threefold change in HIV RNA level for the 16 weeks prior to enrollment. All subjects were required to have prior experience smoking marijuana (defined as six or more times) to ensure that they knew how to inhale and what neuropsychiatric effects to expect.

Exclusion criteria included the following: any active opportunistic infection or malignancy requiring acute treatment; unintentional loss of ≥10 percent of body weight during the past 6 months; current substance dependence; methadone maintenance; use of tobacco or cannabinoids (smoked or oral) within 30 days of enrollment; history of serious pulmonary disease; pregnancy; and Stage II or higher AIDS dementia complex. Laboratory exclusion criteria were hematocrit < 25% and hepatic transaminase elevations to greater than five times the upper limit of normal.

Parallel
Placebo-controlled

Population

Females
Males

No marijuana use

Black or African American
More than one race
White

28

Patient demographics reported include subjects not taking IDV.
Nine subjects' ethnicity is reported as "mixed/other" and is not further specified.
Age (years):

  • < 40: 18 (29%)
  • 40 - 49: 33 (53%)
  • ≥ 50: 11 (18%)

Pharmacokinetic (PK) Sampling Information

Baseline and day 14: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hr post-dose

Empty stomach

Day 14: just prior the second marijuana cigarette; 2, 60 min, 6 hr after smoking

Drug or Natural Product Administration

Object Administration — indinavir

Oral

Capsule (not specified)

2400 mg

800 mg TID

25 days

Precipitant Administration — delta-9-tetrahydrocannabinol (thc)

Inhalation

Cigarette

Up to 3 cigarettes containing 3.95% delta-9-THC

Up to three times, as tolerated, 1 hr prior to meals

21 days

Natural Product Characteristics

The National Institute on Drug Abuse

Not specified