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NCT00082628 · ClinicalTrials.gov registry record · Phase 3
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients
A Phase 3 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT00082628: Completed Phase 3 study, sponsored by EMD Serono.
NCT00082628 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082628, a Phase 3 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study 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.
Primary Outcome
Absolute area of VAT was measured by cross-sectional computed tomography (CT) scan at the level of the L4-5 inter-vertebral disk. CT scanning was to be used to assess the cross sectional area of abdominal fat and its distribution between the visceral and subcutaneous compartments, as measured at L4-L5.
Interventions
- DRUG Placebo
- DRUG Serostim® 4 mg
- DRUG Serostim® 2 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2004-05-28 |
| Est. Completion | 2005-09-28 |
| Phase | Phase 3 |
What the finished NCT00082628 record still lists
NCT00082628 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00082628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00082628 about?
NCT00082628 is a clinical study titled "Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients". 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 e...
What is the current status of trial NCT00082628?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2004-05-28. Estimated completion is 2005-09-28.
What interventions are being tested in trial NCT00082628?
The interventions under investigation include: Placebo (DRUG), Serostim® 4 mg (DRUG), Serostim® 2 mg (DRUG).
Who is sponsoring clinical trial NCT00082628?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00082628's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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