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The study, called "Short Term Effects of Cannabinoids in HIV Patients," will compare HIV-infected patients who smoke marijuana with patients who take an oral tablet of a drug called Marinol-- which contains THC, the active ingredient in marijuana -- with a control group that takes neither.
All the patients will also be taking one of the most commonly prescribed protease inhibitors for their HIV infection, indinavir. "We will be studying several things in these patients," said Donald I. Abrams, M.D., UCSF professor of medicine at the UCSF AIDS Program at San Francisco General Hospital and director of the Community Consortium. "Protease inhibitors, like indinavir, are metabolized by the liver. We want to see if taking THC, either by smoking marijuana or ingesting Marinol, alters the safety or activity of the protease inhibitor."
There are many possible drug interactions with protease inhibitors, Abrams pointed out. Smoking marijuana or taking Marinol could change the concentration of the protease inhibitor in the blood, either creating too high a level and producing toxicities, or too low a level, making the protease inhibitor ineffective.
The study participants will also be monitored for other safety measures, to determine whether marijuana or Marinol has an effect on their HIV viral load, on their immune system or on their hormone levels, particularly testosterone, Abrams said.
"In this study we will be looking at safety first, whether or not there is an impact on the immune system, viral load and hormone levels and how THC affects protease inhibitor metabolism. We will also monitor caloric intake and do some tests of body composition to see if marijuana has any effect on weight gain or increase in appetite," he said. "If it seems safe, then we could go on to look at effectiveness in a future study."
The study, which will begin at the end of 1997, will enroll 63 patients over a period of two years. The patients will be divided into three groups of 21 each. One group will be given marijuana to smoke, one will receive Marinol and the third will be given a Marinol-like tablet that is a placebo (an inert substance).
All of the patients will be housed for 21 days in the General Clinical Research Center (GCRC) at San Francisco General Hospital where they can be monitored carefully. The GCRC is an NIH-funded specialized research unit with highly trained nursing staff, designed to treat patients who are in clinical studies requiring skilled medical care, monitoring and control.
"We believe that because there are a number of HIV-infected patients here in the San Francisco Bay Area who use marijuana, it is important that we get some answers about the safety of using THC," Abrams said. "We are delighted we have been given support from NIH. This study keeps us at the pioneering edge of clinical research in HIV."
The NIH will provide approximately $1 million for the two year study.
Co-researchers are Morris Schambelan, M.D., UCSF professor of medicine, director of the GCRC and co-investigator on the study; Kathleen Mulligan, Ph.D., UCSF assistant professor of medicine, GCRC; Neal Benowitz, M.D., UCSF professor of medicine and pharmacology; Francesca Aweeka, Pharm.D., UCSF clinical pharmacist; Joseph M. McCune, M.D., Ph.D., UCSF associate professor of medicine and associate investigator, Gladstone Institute of Virology and Immunology; Joan Hilton, Sc.D., MPH, UCSF assistant professor of biostatistics/epidemiology; Tarek Elbeik, Ph.D., UCSF assistant researcher/medicine; Thomas Mitchell, MPH, Community Consortium program director.
Marinol is a product of Roxanne Laboratories. Indinavir is produced by Merck & Co.
The Community Consortium is an association of more than 200 Bay Area HIV health care providers who care for the majority of persons with HIV in the Bay Area. Members include health care providers in private practice and those who work at publicly funded clinics, academic medical centers and health maintenance organizations. The Consortium is part of the UC San Francisco AIDS Program at San Francisco General Hospital.
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CONTACT: University of California, San Francisco Alice Trinkl, 415/476-3804
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