July 2, 1998
This open-label observational study enrolled 572 patients (527 men and 45 women) with a mean age of 40 years and a mean baseline weight of 68.1 kilograms. Patients were on stable antiretroviral regimens, had documented weight loss, and had no active opportunistic infections or cancers. All patients were treated daily with 20 mg of oxandralone, an anabolic steroid in pill form. Study visits were scheduled after 1, 2, 4, 8 and 12 months. At each visit, patients were weighed, asked to assess their appetite, sense of well-being, and energy levels, and underwent bioelectric impedance assay (BIA) analysis. BIA measures body cell mass, amount of water in the body, and fat vs. muscle ratio.
Only 26 of the 572 patients had completed the full year-long study before Geneva, but their results, and the interim results from other the patients, were promising. Among the first 26, mean increases in total body weight (and body cell mass, listed in parentheses) were as follows:
Patients' self-assessment also improved, with increased appetite and sense of well-being, and oxandralone was generally well-tolerated, with fewer than one percent of patients experiencing liver function test abnormalities, a side effect associated with anabolic steroids. Most side effects were managed with dose reductions. This study suggests that the muscle loss associated with advanced HIV disease can be reversed, and that oxandralone may be an effective and attractive choice for long-term treatment.