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Sponsored by: |
EMD Serono |
---|---|
Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00489528 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections HIV Wasting Syndrome |
Drug: Somatropin; Recombinant human growth hormone (r hGH) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
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 Start Date: | July 1997 |
Study Completion Date: | March 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Have evidence of AIDS wasting, with at least one of the following:
Meet the following laboratory testing criteria at the week –4 visit (pre study screening):
Be taking an antiretroviral medication that is approved or available under a Treatment IND (in the US) or a temporary approval (outside the US).
Exclusion Criteria:
Any medical history of the following:
Any of the following medical conditions:
Either of the following aspects of the medical regimen in the 30 days prior to study entry (60 days prior to receiving study drug):
Study ID Numbers: | 9037 |
Study First Received: | June 20, 2007 |
Last Updated: | July 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00489528 |
Health Authority: | United States: Food and Drug Administration |
serostim Dose-Response Relationship, Drug Body Composition |
Virus Diseases Sexually Transmitted Diseases, Viral Metabolic Diseases HIV Infections HIV Wasting Syndrome Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Nutrition Disorders Metabolic disorder Wasting Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Pathologic Processes Disease Slow Virus Diseases |
Immune System Diseases Syndrome Lentivirus Infections Infection |