A Study of Megestrol Acetate in HIV-Infected Children

The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.

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.