A Study of Megestrol Acetate in HIV-Infected Children

Gamma Project - ACTU

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Megestrol acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00002182

266A

Gamma 005

Details and patient eligibility

About

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).

Full description

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

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.