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Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection: A Randomized, Placebo-Controlled Clinical Trial

Donald I. Abrams, MD; Joan F. Hilton, DSc; Roslyn J. Leiser, RN; Starley B. Shade, MPH; Tarek A. Elbeik, PhD; Francesca T. Aweeka, PharmD; Neal L. Benowitz, MD; Barry M. Bredt, MA; Bradley Kosel, PharmD; Judith A. Aberg, MD; Steven G. Deeks, MD; Thomas F. Mitchell, MPH; Kathleen Mulligan, PhD; Peter Bacchetti, PhD; Joseph M. McCune, MD, PhD; and Morris Schambelan, MD
[+] Article and Author Information

From the University of California, San Francisco, and Gladstone Institute of Virology and Immunology, San Francisco, California; and the Washington University School of Medicine, St. Louis, Missouri.


Acknowledgments: The authors thank the research nursing and dietary staff at the San Francisco General Hospital General Clinical Research Center for the professionalism and compassion with which they conducted the trial. They also appreciate the efforts of the San Francisco General Hospital inpatient research pharmacy staff and are deeply indebted to the committed study participants. The authors also thank Bayer Diagnostics for providing the VERSANT HIV-1 RNA 3.0 Assays and disposables and Roxane Laboratories for the dronabinol and placebo capsules. Finally, the authors thank Dr. Jag H. Khalsa of the Center on AIDS and Other Medical Consequences of Drug Abuse at the National Institute on Drug Abuse for his thoughtful guidance and constant support, and Rick Doblin, PhD, for his inspiration and persistence.

Grant Support: By National Institutes of Health grants 1RO1 DA/MH11607, 5-MO1-RR00083, and P30-MH59037.

Potential Financial Conflicts of Interest:Consultancies: N.L. Benowitz (Alexza Molecular Delivery Corp.); Honoraria: D.I. Abrams (Solvay Pharmaceuticals), T.A. Elbeik (Bayer Diagnostics), F.T. Aweeka (Merck & Co.); Stock ownership or options (other than mutual funds): N.L. Benowitz (Alexza Molecular Delivery Corp.); Grants received: T.A. Elbeik (Bayer Diagnostics, Cellestics Ltd., Roche Molecular Systems), F.T. Aweeka (Agouron Pharmaceuticals).

Requests for Single Reprints: Donald I. Abrams, MD, University of California, San Francisco, Positive Health Program, Ward 84, 995 Potrero Avenue, San Francisco, CA 94110.

Current Author Addresses: Drs. Abrams and Deeks: University of California, San Francisco, Positive Health Program, Ward 84, 995 Potrero Avenue, San Francisco, CA 94110.

Dr. Hilton: 500 Parnassus Avenue, San Francisco, CA 94143-0560.

Ms. Leiser: University of California, San Francisco, 143 Stillings Avenue, San Francisco, CA 94131.

Mr. Shade and Mr. Mitchell: University of California, San Francisco, 3180 18th Street, Suite 201, San Francisco, CA 94110.

Drs. Elbeik and Benowitz and Mr. Bredt: University of California, San Francisco, 1001 Potrero Avenue, San Francisco, CA 94110.

Dr. Aweeka: University of California, San Francisco, 521 Parnassus Avenue, San Francisco, CA 94143-0622.

Dr. Kosel: University of Washington, 325 9th Avenue, Seattle, WA 98104.

Dr. Aberg: Washington University, 4511 Forest Park, St. Louis, MO 63108.

Dr. Mulligan: San Francisco General Hospital, 1001 Potrero Avenue, Building 30, R3501D, San Francisco, CA 94110.

Dr. Bacchetti: University of California, San Francisco, 500 Parnassus Avenue, Room 423A West, San Francisco, CA 94143-0560.

Dr. McCune: Gladstone Institute, PO Box 419100, San Francisco, CA 94141-9100.

Dr. Schambelan: San Francisco General Hospital, Building 5, 5B6, San Francisco, CA 94110.

Author Contributions: Conception and design: D.I. Abrams, J.F. Hilton, R.J. Leiser, S.B. Shade, T.A. Elbeik, F.T. Aweeka, N.L. Benowitz, T.F. Mitchell, K. Mulligan, J.M. McCune, M. Schambelan.

Analysis and interpretation of the data: D.I. Abrams, J.F. Hilton, S.B. Shade, T.A. Elbeik, F.T. Aweeka, N.L. Benowitz, B.M. Bredt, B. Kosel, K. Mulligan, P. Bacchetti, J.M. McCune, M. Schambelan.

Drafting of the article: D.I. Abrams, J.F. Hilton, T.A. Elbeik, S.G. Deeks, T.F. Mitchell, J.M. McCune.

Critical revision of the article for important intellectual content: D.I. Abrams, J.F. Hilton, R.J. Leiser, S.B. Shade, T.A. Elbeik, F.T. Aweeka, N.L. Benowitz, B.M. Bredt, B. Kosel, J.A. Aberg, S.G. Deeks, T.F. Mitchell, K. Mulligan, P. Bacchetti, J.M. McCune, M. Schambelan.

Final approval of the article: D.I. Abrams, S.B. Shade, F.T. Aweeka, N.L. Benowitz, B.M. Bredt, J.A. Aberg, S.G. Deeks, T.F. Mitchell, K. Mulligan, P. Bacchetti, J.M. McCune, M. Schambelan.

Provision of study materials or patients: D.I. Abrams, R.J. Leiser, T.A. Elbeik, J.A. Aberg, S.G. Deeks.

Statistical expertise: J.F. Hilton, S.B. Shade, P. Bacchetti.

Obtaining of funding: D.I. Abrams, J.F. Hilton, T.A. Elbeik, T.F. Mitchell.

Administrative, technical, or logistic support: R.J. Leiser, S.B. Shade, T.A. Elbeik, B.M. Bredt, J.A. Aberg, S.G. Deeks, T.F. Mitchell, M. Schambelan.

Collection and assembly of data: R.J. Leiser, T.A. Elbeik, F.T. Aweeka, B.M. Bredt, B. Kosel, S.G. Deeks, K. Mulligan, M. Schambelan.


Ann Intern Med. 2003;139(4):258-266. doi:10.7326/0003-4819-139-4-200308190-00008
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This study provides evidence that short-term use of cannabinoids, either oral or smoked, does not substantially elevate viral load in individuals with HIV infection who are receiving stable antiretroviral regimens containing nelfinavir or indinavir. Upper confidence bounds for all estimated effects of cannabinoids on HIV RNA level from all analyses were no greater than an increase of 0.23 log10 copies/mL compared with placebo. Because this study was randomized and analyses were controlled for all known potential confounders, it is very unlikely that chance imbalance on any known or unknown covariate masked a harmful effect of cannabinoids. Study participants in all groups may have been expected to benefit from the equivalent of directly observed antiretroviral therapy, as well as decreased stress and, for some, improved nutrition over the 25-day inpatient stay.

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Figures

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Figure 1.
Flow of participants through the randomized trial.

THC = tetrahydrocannabinol.

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Figure 2.
Changes in CD4 + and CD8 + cell counts by group (n= 62).Top.+Bottom.+

Median change in CD4 cell counts over the 21-day study period. Median change in CD8 cell counts over the 21-day study period.

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Summary for Patients

Does Marijuana Affect Viral Loads in People with HIV?

The summary below is from the full report titled “Short-Term Effects of Cannabinoids in Patients with HIV-1 Infection. A Randomized, Placebo-Controlled Clinical Trial.” It is in the 19 August 2003 issue of Annals of Internal Medicine (volume 139, pages 258-266). The authors are D.I. Abrams, J.F. Hilton, R.J. Leiser, S.B. Shade, T.A. Elbeik, F.T. Aweeka, N.L. Benowitz, B.M. Bredt, B. Kosel, J.A. Aberg, S.G. Deeks, T.F. Mitchell, K. Mulligan, P. Bacchetti, J.M. McCune, and M. Schambelan.

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