A Study of Megestrol Acetate in HIV-Infected Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Megestrol acetate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Univ of Puerto Rico / Med Science Campus

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

Other Identifiers

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Gamma 005

Identifier Type: -

Identifier Source: secondary_id

266A