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A Study of Megestrol Acetate in HIV-Infected Children

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ClinicalTrials.gov Identifier: NCT00002182
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

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).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Megestrol acetate Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Megestrol Acetate For Failure To Thrive In Pediatric HIV

Resource links provided by the National Library of Medicine

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





Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002182


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

ClinicalTrials.gov Identifier: NCT00002182     History of Changes
Other Study ID Numbers: 266A
Gamma 005
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Placebos
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
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