Articles19 August 2003
A Randomized, Placebo-Controlled Clinical Trial
    Author, Article, and Disclosure Information
    Background:

    Cannabinoid use could potentially alter HIV RNA levels by two mechanisms: immune modulation or cannabinoidprotease inhibitor interactions (because both share cytochrome P-450 metabolic pathways).

    Objective:

    To determine the short-term effects of smoked marijuana on the viral load in HIV-infected patients.

    Design:

    Randomized, placebo-controlled, 21-day intervention trial.

    Setting:

    The inpatient General Clinical Research Center at the San Francisco General Hospital, San Francisco, California.

    Participants:

    67 patients with HIV-1 infection.

    Intervention:

    Participants were randomly assigned to a 3.95%-tetrahydrocannabinol marijuana cigarette, a 2.5-mg dronabinol (delta-9-tetrahydrocannabinol) capsule, or a placebo capsule three times daily before meals.

    Measurements:

    HIV RNA levels, CD4+ and CD8+ cell subsets, and pharmacokinetic analyses of the protease inhibitors.

    Results:

    62 study participants were eligible for the primary end point (marijuana group, 20 patients; dronabinol group, 22 patients; and placebo group, 20 patients). Baseline HIV RNA level was less than 50 copies/mL for 36 participants (58%), and the median CD4+ cell count was 340 × 109 cells/L. When adjusted for baseline variables, the estimated average effect versus placebo on change in log10 viral load from baseline to day 21 was 0.07 (95% CI, 0.30 to 0.13) for marijuana and 0.04 (CI, 0.20 to 0.14) for dronabinol. The adjusted average changes in viral load in marijuana and dronabinol relative to placebo were 15% (CI, 50% to 34%) and 8% (CI, 37% to 37%), respectively. Neither CD4+ nor CD8+ cell counts appeared to be adversely affected by the cannabinoids.

    Conclusions:

    Smoked and oral cannabinoids did not seem to be unsafe in people with HIV infection with respect to HIV RNA levels, CD4+ and CD8+ cell counts, or protease inhibitor levels over a 21-day treatment.

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