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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00082628

Public ClinicalTrials.gov record NCT00082628. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 7:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00082628
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
EMD Serono
Industry
Enrollment
326 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 60 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 28, 2004 (Actual)
Primary completion
Sep 28, 2005 (Actual)
Completion
Sep 28, 2005 (Actual)
Last update posted
Jul 20, 2018

2004 – 2005

United States locations

U.S. sites
30
U.S. states
14
U.S. cities
25
Facility City State ZIP Site status
University of Alabama/Birmingham Birmingham Alabama 35294 —
CARE CLINIC - UCLA Medical Center Los Angeles California 90095 —
1401 N. Palm Canyon Palm Springs California 92262 —
Trials Unit Div of Infectious and Immunologic Diseases Sacramento California 95817 —
UCSD - AntiViral Research Center San Diego California 92103 —
University of California, San Francisco - Div. of Endocrinology San Francisco California 94110 —
Kaiser Permanente San Francisco California 94118 —
Northern California Institute for Research and Education, Inc. San Francisco California 94121 —
Harbor-UCLA Medical Ctr Research & Education Institute Torrance California 90502 —
AIDS Alliance West Hollywood California 90069 —
University of Colorado Health Sciences Center Denver Colorado 80262 —
1640 Rhode Island Avenue, N.W. Washington D.C. District of Columbia 20036 —
Office Of Dr Gary Richmond Fort Lauderdale Florida 33316 —
3661 South Miami Avenue Miami Florida 33133 —
Care Resources Miami Florida 33137 —
Infectious Disease Associates Sarasota Florida 34239 —
AIDS Research Consortium of Atlanta Atlanta Georgia 30308 —
Rush University Medical Center Chicago Illinois 60612 —
Indiana University Infectious Disease Research Clinic Indianapolis Indiana 46202 —
Tufts University School of Medicine Boston Massachusetts 02111 —
Community Research Initiative of New England Boston Massachusetts 02215 —
Community Research Initiative Of New England Springfield Massachusetts 01107 —
Hennepin County Medical Center Minneapolis Minnesota 55415 —
Albany Medical College Albany New York 12208 —
Weill Medical College of Cornell Universtiy New York New York 10021 —
St. Luke's Roosevelt Hospital New York New York 10025 —
Bronx Women's Interagency HIV Study The Bronx New York 10467 —
Central Texas Clincial research Austin Texas 78705 —
IDP Research Annandale Virginia 22003 —
Office of Daniel Coulston, M.D. Spokane Washington 99204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00082628, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 20, 2018 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00082628 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →