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A Study of Megestrol Acetate in HIV-Infected Children

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
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 Intervention
HIV Infections Drug: Megestrol acetate

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

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 25
Detailed Description:
The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.

Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
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
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Please refer to this study by its identifier: NCT00002182

Puerto Rico
Univ of Puerto Rico / Med Science Campus
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Gamma Project - ACTU
  More Information Identifier: NCT00002182     History of Changes
Other Study ID Numbers: 266A
Gamma 005
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Appetite Stimulants
Megestrol Acetate
Failure to Thrive

Additional relevant MeSH terms:
HIV Infections
Failure to Thrive
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants processed this record on September 21, 2017