NCT00002182

Completed

A Study of Megestrol Acetate in HIV-Infected Children

Gamma Project - ACTU Source

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Other study identifiers

Sponsor study identifier

266A

Secondary identifiers

Gamma 005

Study Type

interventional

Reported enrollment (type unavailable)

25

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 25 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 2, 1999
Actual (reported)
First Posted
August 31, 2001
Actual (reported)

Last Updated: June 24, 2005
Status Verified: July 1998
Last Update Submitted: June 23, 2005

Conditions

HIV Infections

Keywords

PlacebosAppetite StimulantsMegestrol AcetateFailure to Thrive

Interventions

Megestrol acetateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Patients must have:
Documented HIV infection.

Sponsors & Collaborators

Gamma Project - ACTU
Otherlead

Study Sites (1)

Univ of Puerto Rico / Med Science Campus

San Juan, 00936, Puerto Rico

MeSH Terms

Conditions

HIV InfectionsFailure to Thrive

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type: interventional
Phase: not applicable
Masking: DOUBLE
Purpose: TREATMENT
Sponsor Type: OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00002182
Data provider: ClinicalTrials.gov
Source updated: 2005-06-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:45 UTC

Locations

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NCT00490412

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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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Immunologic Deficiency Syndromes

Immune System Diseases

Signs and Symptoms

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

PR

(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Intervention Hierarchy (Ancestors)