A Study of Megestrol Acetate in HIV-Infected Children

G

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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