Growth Hormone in the Treatment of HIV-Associated Wasting
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; HIV Wasting Syndrome
Intervention: Somatropin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: EMD Serono
Summary
The purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug.
Clinical Details
Official title:
A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Recombinant Human Growth Hormone (Serostim) in the Treatment of HIV-Associated Catabolism/Wasting
Study design: Interventional, Treatment, Parallel Assignment, Efficacy Study
Detailed description:
Patients are selected randomly to receive full-dose somatropin, half-dose somatropin, or placebo. Clinical assessments are taken at Week 12. Patients who reach the primary study endpoint will be eligible for a 12-week ancillary course of somatropin treatment at the full dose.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- Have HIV infection.
- Have HIV/AIDS wasting or severe weight loss or malnutrition.
- Are at least 18 years old.
- Meet treatment, medication, and nutrition requirements.
- Are taking anti-HIV medications.
Locations and Contacts
Clinical Trial Information, Norwell, Massachusetts 02061, United States
Additional Information
Ending date: August 2001
Last updated: June 23, 2005
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