Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection: A Randomized, Placebo-Controlled Clinical Trial
Publication: Annals of Internal Medicine
Volume 139, Number 4
Abstract
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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Information & Authors
Information
Published In
Annals of Internal Medicine
Volume 139 • Number 4 • 19 August 2003
Pages: 258 - 266
History
Published online: 19 August 2003
Published in issue: 19 August 2003
Keywords
- Addiction
- Biochemistry
- Cannabis
- Drugs
- Enzyme inhibitors
- Enzymology
- Genetics
- Health care
- HIV
- HIV infections
- Infectious diseases
- Microbiology
- Patients
- Pharmacokinetics
- Pharmacology
- Prevention, policy, and public health
- Psychiatry and mental health
- Recreational drug use
- Research and reporting methods
- Retroviruses
- RNA
- RNA viruses
- Safety
- Viral diseases
- Viral transmission and infection
- Virology
Copyright
© 2003 American College of Physicians.
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Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection: A Randomized, Placebo-Controlled Clinical Trial. Ann Intern Med.2003;139:258-266. [Epub 19 August 2003]. doi:10.7326/0003-4819-139-4-200308190-00008
Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection: A Randomized, Placebo-Controlled Clinical Trial. Ann Intern Med.2003;139:258-266. [Epub 19 August 2003]. doi:10.7326/0003-4819-139-4-200308190-00008
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