Completed
Megestrol Acetate for Improved Growth in HIV-Affected Children
What is being tested
Megestrol acetate
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
From 6 Months to 18 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGamma Project - ACTU
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.
Principal SponsorGamma Project - ACTU
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 Months to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsFailure to ThriveHIV Infections
Criteria
5 inclusion criteria required to participate
Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
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.
Free of significant acute illness (mild upper respiratory tract infections allowed).
Documented HIV infection.
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6 exclusion criteria prevent from participating
Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.
Significant acute illness.
Gastrointestinal infection or malabsorption.
Medical contraindications to megestrol acetate.
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Univ of Puerto Rico / Med Science Campus
San Juan, Puerto RicoOpen Univ of Puerto Rico / Med Science Campus in Google MapsCompletedOne Study Center