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A Study of Megestrol Acetate in HIV-Infected Children

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002182
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Megestrol Acetate For Failure To Thrive In Pediatric HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002182

Locations
Puerto Rico
Univ of Puerto Rico / Med Science Campus
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Gamma Project - ACTU
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002182     History of Changes
Other Study ID Numbers: 266A, Gamma 005
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Growth Disorders
Pathologic Processes
Megestrol
 Megestrol Acetate
Appetite Stimulants
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013