UCSF Study Finds No Harm to HIV+ Patients with Short-Term Medical Cannabis
Pubdate: Mon, 18 Aug 2003
Source: Annals of Internal Medicine
UCSF Study Finds No Harm to HIV+ Patients with Short-Term Medical
UCSF researchers found no harmful changes in HIV virus levels in
patients on combination antretroiviral therapy in a safety study looking
at both smoked marijuana and dronabinol, an oral medical cannabinoid.
"People with HIV are a vulnerable population, so successfully addressing
the safety concerns allows us to move on to effectiveness studies, three
of which are currently underway here," said study author Donald Abrams,
MD, professor of clinical medicine in the UCSF Positive Health Program
at San Francisco General Hospital Medical Center (SFGHMC).
The findings, which appear in the August 19, 2003 issue of the Annals of
Internal Medicine, mark the first publication of a randomized,
controlled study involving medical marijuana in a major peer-reviewed
journal in several years.
Sixty-two HIV-infected patients on antiretroviral regimens containing a
protease inhibitor completed the 25 day inpatient study. Patients were
randomized to three groups--20 received smoked marijuana, 22 received
dronabinol, and 20 received an oral placebo.
The study measured changes in HIV virus levels in blood (rising levels
tend to indicate disease progression) and CD 4 and CD 8 T lymphocyte
These disease- fighting white blood cells are essential for defending
against infections and are targeted and destroyed by the HIV virus.
The study investigated whether cannabinoids would alter the levels of
the virus either by changing the levels of the protease inhibitor
medication or by a direct effect on the immune system. Fifty-eight
percent of the participants entered the study with levels of HIV virus
circulating in their blood below the limit currently detectable by the
usual tests. They ended the study with no change in their undetectable
status. In all three arms, patients with detectable levels of virus saw
no change in the levels of HIV in their blood over the three-week study
period. There was no significant change in CD 4 or CD 8 T-cell counts
for the placebo group over the course of the study. CD 4 T-cell counts
rose by about 20 percent for both the smoked marijuana and the
dronabinol group. CD 8 T-cell counts rose by 20 percent in the smoked
marijuana group and by 10 percent in the dronabinol group. "The change
in lymphocyte counts for the smoked marijuana group is intriguing. At a
minimum, it contradicts findings from previous studies suggesting that
smoked marijuana suppresses the immune system," said Abrams.
While not the primary objective of the study, weight gain was observed
in all three groups, possibly due to regularly scheduled meals and
Statistically significant weight gain occurred in both the smoked
marijuana and the dronabinol arms compared with the placebo arm, though
the gain was fat, not in the desired lean body mass compartment.
Co-authors of the study are Joan F. Hilton, DSc, MPH, UCSF associate
professor of epidemiology and biostatistics; Roslyn J. Leiser, RN,
clinical nurse, Starley B. Shade, MPH, senior statistician, Steven G.
Deeks, MD, UCSF associate professor of medicine, and Thomas F. Mitchell,
MPH, program director, all in the UCSF Positive Health Program at
SFGHMC; Tarek A. Elbeik, PhD, UCSF associate researcher in laboratory
medicine at SFGHMC; Francesca T. Aweeka, PharmD, UCSF professor of
clinical pharmacology; and Neal L. Benowitz, MD, UCSF chief of the
division of clinical pharmacology and vice chair of the department of
biopharmaceutical sciences. Also, Barry M. Bredt, MA, specialist, and
Morris Schambelan, MD, UCSF professor of medicine and director, General
Clinical Research Center at SFGHMC; Bradley Kosel, PharmD, visiting
postdoctoral scholar in clinical pharmacology at UCSF; Judith A. Aberg,
MD, associate professor of medicine at Washington University, St. Louis,
Mo.; Kathleen Mulligan, PhD, UCSF associate professor of medicine at
SFGHMC; and Joseph M. McCune, MD, PhD, UCSF professor of medicine at the
Gladstone Institute of Virology and Immunology.
The study was supported by a research grant from the National Institute
on Drug Abuse, a part of the National Institutes of Health, which also
supplied the marijuana cigarettes for the trial. The dronabinol and
placebo were supplied by Roxane, Inc., Columbus, Ohio.
Distributed without profit to those who have expressed a prior interest in
receiving the included information for research and educational purposes.