HIV Infections
Conditions
Keywords
Placebos, Appetite Stimulants, Megestrol Acetate, Failure to Thrive
Brief summary
The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).
Detailed description
The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.
Interventions
DRUGMegestrol acetate
Sponsors
Gamma Project - ACTU
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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.
Countries
Puerto Rico
Outcome results
None listed