Trials / Completed
CompletedNCT00082628
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Serostim®, r-hGH in the Treatment and Maintenance of Human Immunodeficiency HIV-Associated Adipose Redistribution Syndrome, or HARS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- EMD Serono · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo matched to serostim® as subcutaneous injection. |
| DRUG | Serostim® 4 mg | Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight. |
| DRUG | Serostim® 2 mg | Serostim® 2 mg as subcutaneous injection on alternate days. |
Timeline
- Start date
- 2004-05-28
- Primary completion
- 2005-09-28
- Completion
- 2005-09-28
- First posted
- 2004-05-17
- Last updated
- 2018-07-20
- Results posted
- 2018-07-20
Locations
31 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00082628. Inclusion in this directory is not an endorsement.