- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002182
A Study of Megestrol Acetate in HIV-Infected Children
June 23, 2005 updated by: Gamma Project - ACTU
Megestrol Acetate For Failure To Thrive In Pediatric HIV
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).
Study Overview
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
Enrollment
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00936
- Univ of Puerto Rico / Med Science Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
July 1, 1998
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Failure to Thrive
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 266A
- Gamma 005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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