First Patients Enrolled In NIH Clinical Trial On Effects Of Marijuana In HIV Patients

May 21, 1998

A clinical trial on the effects of marijuana in patients with HIV infection has begun under the direction of a group of physician-scientists in San Francisco.

Supported by a $1 million grant from the National Institutes of Health, the two-year study is a combined project of UC San Francisco and the Community Consortium, a Bay Area association of 200 health care providers who care for the majority of HIV/AIDS patients in the region.

The trial will examine the influence of marijuana on the immune system and on the amount of virus in the body, as well as on its potential interactions with antiviral drugs such as protease inhibitors.

Named the "Short-Term Effects of Cannabinoids in HIV Patients," the clinical trial began last week. A total of 63 patients are scheduled to be enrolled over the next 18 months. In order to be eligible for the study, patients must already be undergoing treatment with either indinavir or nelfinavir, the two most commonly prescribed protease inhibitors for HIV infection.

"Our main goal is find out what is safe for HIV/AIDS patients. We know many patients use marijuana to relieve nausea and loss of appetite brought on by the disease and its treatments, but we don't know how THC--the active ingredient in marijuana--interacts with HIV drug therapies," said Donald I. Abrams, MD, who is principal investigator of the study.

"For example, protease inhibitors like indinavir and nelfinavir are metabolized by the liver, as is THC. We want to see if THC alters the metabolism of protease inhibitors and therefore changes the concentration of the drug in the blood, either creating a level that is too high, producing toxicities, or is too low, rendering the protease inhibitor ineffective," he said.

Abrams is UCSF professor of medicine at the UCSF AIDS Program at San Francisco General Hospital and director of the Community Consortium.

Patients in the trial will be randomly assigned to one of three groups, each with 21 participants. One group will be given marijuana to smoke, one will receive an oral tablet called Marinol that contains THC, and the third will serve as a control group with patients receiving a placebo tablet that contains inactive ingredients.

All of the patients will be housed for 25 days in the General Clinical Research Center (GCRC) at SFGH where they will be monitored carefully. The GCRC is an NIH-funded specialized research unit designed to treat patients who are in clinical studies requiring skilled medical and nursing care, monitoring, and control.

In addition to studying the pharmacokinetics of THC and antiviral drug interactions, the research team will monitor caloric intake of patients and conduct tests of body composition to see if THC has any effect on weight gain or increase in appetite. Patients also will be evaluated for the effect on hormone levels, particularly testosterone, in the blood.

"With this study, Bay Area AIDS specialists continue to be at the pioneering edge of clinical research in HIV," Abrams said. "The findings will help us provide better treatment to patients and to plan future clinical research protocols."

Co-researchers are Morris Schambelan, MD, UCSF professor of medicine, director of the GCRC at SFGH and co-investigator on the study; Kathleen Mulligan, PhD, UCSF assistant professor of medicine, GCRC; Neal Benowitz, MD, UCSF professor of medicine and pharmacology; Francesca Aweeka, PharmD, UCSF clinical pharmacist; Joseph M. McCune, MD, PhD, UCSF associate professor of medicine and associate investigator, Gladstone Institute of Virology and Immunology; Joan Hilton, ScD, MPH, UCSF assistant professor of biostatistics/epidemiology; Tarek Elbeik, PhD, UCSF assistant researcher/medicine; Roz Leiser, RN, Community Consortium study coordinator; and Thomas Mitchell, MPH, Community Consortium program director.

Marinol is a product of Roxane Laboratories, Inc. Indinavir is produced by Merck & Company and nelfinavir by Agouron Pharmaceuticals.

The Community Consortium was formed in 1985. Its membership includes health care providers in private practice and those who work at publicly-funded clinics, academic medical centers, and health maintenance organizations.

University of California - San Francisco

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