A Study of Megestrol Acetate in HIV-Infected Children

HIV Infections Clinical Trial

Official title:

Megestrol Acetate For Failure To Thrive In Pediatric HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002182
• Other study ID #: 266A
• Secondary ID: Gamma 005
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failure to Thrive
• HIV Infections

Intervention

Drug:
• Megestrol acetate

Locations

Country	Name	City	State
Puerto Rico	Univ of Puerto Rico / Med Science Campus	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
Gamma Project - ACTU

Country where clinical trial is conducted

Puerto Rico,