SAN FRANCISCO: DHEA STUDY RECRUITING

In January 1988, AIDS TREATMENT NEWS reported on DHEA, a hormone which is already present in the body and is closely related to testosterone, and which was being tested as an AIDS treatment in a small study in Paris (see issue #48, January 15, 1988). Recently, at the AIDS conference in Montreal, some DHEA studies suggested that the drug might have a protective effect.

A phase I trial in San Francisco is now recruiting persons who have some ARC symptoms (such as thrush, or hairy leukoplakia, or chronic diarrhea, or fevers and sweats) and T-helper counts between 250 and 600. Persons with an AIDS diagnosis are not eligible for this study (because they meet the FDA criteria for AZT, and therefore it would be considered unethical for researchers to keep them off of that drug). Women also are not eligible, because the drug is a male hormone which might be harmful to them. (If the treatment is determined to be valuable it might be usable by women, but researchers are reluctant to take the increased risk before efficacy has been shown.) Patients cannot use any antiviral with known or suspected anti- HIV activity (such as AZT or dextran sulfate) during the study.

Volunteers will take DHEA by mouth for 16 weeks; there is no placebo. Three different doses are being tested; 250 mg three times a day, and 500 and 750 mg on the same schedule. Patients cannot start on the next higher dose until all have completed eight weeks on the lower dose without harm. (Even the lowest dose in this study is higher than any we reported in the Paris study in 1988.) After the study, the sponsor and the FDA have agreed to provide maintenance of the drug, provided that it is well tolerated and appears to be beneficial.

The trial is sponsored by Elan Corporation, which is based in Ireland, and which also sponsored the Paris study. In San Francisco, the principal investigators are Toby Dyner, M. D., and Mark Jacobson, M. D.

Persons interested in joining this study should call Jaime Geaga at the AIDS Clinical Research Project (ACRE) at Childrens' Hospital; the phone number is 750-6529 or 750-6522. 24 volunteers are needed (eight for each dose level), and six are already enrolled.