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