The Safety and Effectiveness of Megace in HIV-Infected Women

Inclusion Criteria Patient must have: HIV infection. Evidence of HIV wasting syndrome that includes anorexia (appetite fair or poor) and weight loss >= 10 percent of pre-illness body weight. Perception of weight loss as a detriment. Life expectancy of at least 24 weeks. Prior Medication: Allowed: Megestrol acetate for weight gain at a dose < 400 mg for < 60 days, provided therapy was discontinued at least 3 months prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Poorly controlled hypertension. Heart failure. Deep vein thrombosis. Uncontrolled severe diarrhea. Treatable active current infection (excluding chronic low-grade opportunistic infections). Unable to intake food. Impaired digestive/absorptive function. Concurrent Medication: Excluded: Initiation during the study of any therapy to treat HIV or anorexia/cachexia (other than study drug). Patients with the following prior conditions are excluded: Hospitalization for or exacerbation of illness associated with weight loss within the past 2 weeks. Participation in other investigational drug studies within the past month. Previous abnormal mammogram (if 35-40 years of age) or abnormal mammogram within the past year (if over 40 years of age). Prior Medication: Excluded: New antiviral therapy within the past 8 weeks. Medications to promote weight gain (e.g., corticosteroid, dronabinol) within the past 2 months. Megestrol acetate within the past 3 months. IV drug abuse not treated for at least 4 months.