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 Ago
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Contact: Corinna Kaarlela
corinna@itsa.ucsf.edu
(415) 476-3804
University of California - San Francisco
21-May-1998