San Francisco: Weight Loss/Megace Study

The San Francisco County Community Consortium is currently recruiting patients for a phase III study of megestrol acetate (Megace), a drug which may be useful in reversing HIV- related wasting syndrome (cachexia). Marked weight loss is a serious problem for some people with HIV disease. It can further impair an immune system already damaged by the virus, resulting in an increased susceptibility to opportunistic infections.

The rationale for this study is based on observations from another study conducted at the University of Maryland which found that 28 of 30 patients being treated for breast cancer with Megace experienced increased appetite and weight gain. Although this side effect was beneficial for the patients, it was also unexpected, so that important nutritional data was not collected.

The trial, conducted by Consortium physicians through their private practices, is one of the first community-based trials in the greater Bay Area. The trial seeks to determine if the weight gain associated with Megace is comprised of protein or fat, or merely water retention, and what relationship there is between immune status and general or specific nutritional status. This is a placebo-controlled study, but it is also a "cross-over" study, which means that halfway through (after eight weeks), the treatment/placebo arms will be switched, so that by the end of the study everyone will have received active drug.

Note that Megace is a prescription drug; if someone is now seriously anorectic, they could discuss the immediate use of Megace with their physician. Last December, AIDS Treatment News #71 reported on the good results with Megace for AIDS- related cachexia published in the November 15, 1988 issue of Annals of Internal Medicine.

We were assured that participants will be closely monitored by physicians, nurses and nutritionists to watch for any weight loss severe enough to warrant withdrawal from the study. Megace and all laboratory tests required by the study are provided free of charge. In addition, all patients will receive monthly feedback on their nutritional status by a registered dietitian.

Eligibility criteria for the study include either asymptomatic HIV infection or ARC and a documented loss of at least 5% of usual body weight. Persons with AIDS-defining diagnoses are excluded.

To determine whether your physician is a member of the San Francisco County Community Consortium, or for more information about the study, call Helen Mudie at 415/821- 5495, or Ann Conroy at 415/565-6649.