A Study of Megestrol Acetate in HIV-Infected Children

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gamma Project - ACTU
• Treatments: Megestrol; Megestrol Acetate

Criteria

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.