A Study of Megestrol Acetate in HIV-Infected Children

Inclusion Criteria Patients must have: Documented HIV infection. Failure to thrive as defined by: crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight. Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements). Free of significant acute illness (mild upper respiratory tract infections allowed). Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out. Exclusion Criteria Co-existing Condition: Patients with the following symptoms are excluded: Gastrointestinal infection or malabsorption. Significant acute illness. Any identified, untreated cause for failure to thrive other than underlying HIV infection. Medical contraindications to megestrol acetate. Patients with any of the following prior conditions or symptoms are excluded: Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure. History of prior megestrol acetate therapy in the past six months.