Clinical Trial: Growth Hormone in the Treatment of HIV-Associated Wasting

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: EMD Serono

Current Primary Outcome: To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.

Original Primary Outcome: Same as current

Current Secondary Outcome: To establish an optimal dose of Serostim, based on the endpoint of lean body mass (LBM) change.

Original Secondary Outcome: Same as current

Information By: EMD Serono

Dates:
Date Received: June 20, 2007
Date Started: July 1997
Date Completion:
Last Updated: October 21, 2013
Last Verified: October 2013