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A Study of Megestrol Acetate in HIV-Infected Children

Sponsor
Gamma Project - ACTU (Other)
Overall Status
Completed
CT.gov ID
NCT00002182
Collaborator
(none)
25
Enrollment
1
Location

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Megestrol acetate
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Megestrol Acetate For Failure To Thrive In Pediatric HIV

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univ of Puerto Rico / Med Science Campus San Juan Puerto Rico 00936

    Sponsors and Collaborators

    • Gamma Project - ACTU

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002182
    Other Study ID Numbers:
    • 266A
    • Gamma 005
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jul 1, 1998
    Keywords provided by , ,
    Placebos
    Appetite Stimulants
    Megestrol Acetate
    Failure to Thrive
    Additional relevant MeSH terms:
    HIV Infections
    Failure to Thrive
    Megestrol
    Megestrol Acetate

    Study Results

    No Results Posted as of Jun 24, 2005