drugset / Trial / NCT00082628

Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients

NCT00082628

Phase 3 Completed 326 enrolled EMD Serono
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.

Timeline

Start
2004-05-28
Primary completion
2005-09-28
Completion
2005-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic 2 mg Subcutaneous
Subject Somatropin Protein / enzyme biologic 4 mg Subcutaneous