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UNIMED’s MARINOL, BRISTOL’s MEGACE ENTER PHASE I/II FOR HIV- WASTING

Executive Summary

UNIMED's MARINOL, BRISTOL's MEGACE ENTER PHASE I/II FOR HIV- WASTING syndrome as the first trial of the new National Institute of Allergy and Infectious Diseases clinical trials network, NIAID announced March 31. Unimed/Roxane Laboratories' Marinol (dronabinol, THC) and Bristol-Myers Squibb's Megace (megestrol) will be studied alone and in combination during the 12-week trial, which will enroll 56 patients at eight clinical sites. Dronabinol currently is approved for oral treatment of nausea and vomiting associated with cancer chemotherapy. The synthetic hormone megestrol acetate is approved for the treatment of breast cancer. "Previous studies have suggested that both [dronabinol and megestrol acetate] stimulate the appetite and reverse weight loss among persons with HIV," an NIAID release notes. Trial participants will be randomly assigned to one of four groups. The first group will receive dronabinol twice a day, and the second will receive megestrol acetate once a day. Groups three and four will take either a high or low dose of megestrol acetate once a day plus dronabinol twice a day. Patients will be eligible if they have lost 10% of their body weight since becoming infected with HIV and have continued to lose weight in the three months prior to trial enrollment. The study began the week of March 16. The NIAID trials network is called "DATRI," the Division of AIDS Treatment Research Initiative. Unlike NIAID's two other networks, the AIDS Clinical Trials Group (ACTG) and the Community Programs for Clinical Research on AIDS (CPCRA), which pursue investigator-initiated trials, DATRI studies are chosen by NIAID's Division of AIDS and conducted through a contract mechanism. Under the DATRI program, Westat Inc. of Rockville, Md. has a $30.7 mil. five-year contract to conduct clinical trials through the network. NIAID has selected three permanent subcontractors, the University of Maryland, Social and Scientific Systems and ERC Bioservices, to serve as scientific coordinators. Duncan noted that 24 ACTGs, six CPCRAs, 12 major medical centers and three community-based sites are eligible to participate in the program. NIAID staffer William Duncan described three additional upcoming DATRI trials at a March 30 meeting of the institute's AIDS Research Advisory Committee. DATRI 001 will evaluate the safety, tolerance and pharmacokinetics of rifabutin/clarithromycin versus rifabutin/azithromycin for treatment of disseminated MAC (Mycobacterium avium complex) in HIV-infected patients. The Phase I/II study, slated to begin in early April, is expected to enroll 78 patients at up to eight clinical sites. Duncan said NIAID "hopes this trial will provide the basis for a larger efficacy trial, such as a Phase III trial in the ACTG." Adria Labs has a Treatment IND for rifabutin (Mycobutyin) to prevent or delay MAC in AIDS patients with a CD4 cell count less than 200/mm ("The Pink Sheet" March 9, T&G-13). Azithromycin (Pfizer's Zithromax) and clarithromycin (Abbott Labs' Biaxin) were approved in late 1991 for non-AIDS related uses. DATRI 002 proposes to "evaluate the efficacy of AZT in preventing CD4 lymphocyte decline in primary HIV infection," according to Duncan. NIAID plans to enroll 80 high-risk patients, such as intravenous drug users and people with a history of sexually transmitted diseases, at 10 sites. The trial is expected to begin in June. The third study, DATRI 003, will assess viral burden in peripheral blood versus lymphatic tissue in HIV-infected patients before and after antiretroviral therapy. Slated to begin in April, the trial is expected to enroll 32 patients at eight clinical sites.
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