Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized, placebo-controlled clinical trial


Donald I Abrams, Joan F Hilton, Roslyn J Leiser, Starley B Shade, Tarek A Elbeik, Francesca T Aweeka, Neal L Benowitz, Barry M Bredt, Bradley Kosel, Judith A Aberg, Steven G Deeks, Thomas F Mitchell, Kathleen Mulligan, Peter Bacchetti, Joseph M McCune, Morris Schambelan

Published in Annals of Internal Medicine

August 2003


Cannabinoid use could potentially alter HIV RNA levels by two mechanisms: immune modulation or cannabinoid-protease 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 x 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.

Open Access


DOI: 10.7326/0003-4819-139-4-200308190-00008


Abrams, D. I., Hilton, J. F., Leiser, R. J., Shade, S. B., Elbeik, T. A., Aweeka, F. T., … & Schambelan, M. (2003). Short-term effects of cannabinoids in patients with HIV-1 infection: a randomized, placebo-controlled clinical trial. Annals of internal medicine, 139(4), 258-266.