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
Sponsor study identifier
interventional
326
2 countries
31
Study Start
May 28, 2004
Actual (reported)Primary Completion
September 28, 2005
Actual (reported)Study Completion
September 28, 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 28, 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2004
Actual (reported)May 17, 2004
Actual (reported)May 28, 2004
Actual (reported)September 28, 2005
Actual (reported)September 28, 2005
Actual (reported)July 20, 2018
Actual (reported)Treatment Period I: Change From Baseline in Absolute Area of Visceral Adipose Tissue (VAT) at Week 12
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.
Baseline, Week 12
Treatment Period I: Change From Baseline in Trunk Fat at Week 12
Baseline, Week 12
Change From Baseline in Patient Reported Outcome of Body Image Distress at Week 12
Baseline, Week 12
Treatment Period I: Change From Baseline in Non- High-density Lipoprotein (Non-HDL) Cholesterol at Week 12
Baseline, Week 12
Treatment Period II: Failure Rate at Week 36 Based on Visceral Adipose Tissue (VAT) For Subjects Who Received Serostim® 4 mg in Period I
Week 36
Subjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
Subjects will receive Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight for a period of 12 weeks.
All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive placebo matched to Serostim® on alternate days for 24 weeks in Period II.
Placebo matched to serostim® as subcutaneous injection.
Serostim® as subcutaneous injection at a maximum dose of 4 milligram (mg) per day based on body weight.
University of Alabama/Birmingham
Birmingham, Alabama, 35294, United States
CARE CLINIC - UCLA Medical Center
Los Angeles, California, 90095, United States
1401 N. Palm Canyon
Palm Springs, California, 92262, United States
Trials Unit Div of Infectious and Immunologic Diseases
Sacramento, California, 95817, United States
UCSD - AntiViral Research Center
San Diego, California, 92103, United States
University of California, San Francisco - Div. of Endocrinology
San Francisco, California, 94110, United States
Kaiser Permanente
Medical Responsible
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
326 participants (actual enrollment reported by the registry).
First Submitted
May 13, 2004
First Posted
May 17, 2004
Study Start
May 28, 2004
Actual (reported)T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs
All subjects who will be initially randomized to Serostim® 4 mg arm in Period I and will receive Serostim® 2 mg on alternate days for 24 weeks in Period II.
All subjects who will be initially randomized to Placebo arm in Period I continue receiving placebo matched to Serostim® on alternate days for 12 weeks followed by Serostim® 4 mg daily 12 weeks.
Serostim® 2 mg as subcutaneous injection on alternate days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
San Francisco, California, 94118, United States
Northern California Institute for Research and Education, Inc.
San Francisco, California, 94121, United States
Harbor-UCLA Medical Ctr Research & Education Institute
Torrance, California, 90502, United States
AIDS Alliance
West Hollywood, California, 90069, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
1640 Rhode Island Avenue, N.W.
Washington D.C., District of Columbia, 20036, United States
Office Of Dr Gary Richmond
Fort Lauderdale, Florida, 33316, United States
3661 South Miami Avenue
Miami, Florida, 33133, United States
Care Resources
Miami, Florida, 33137, United States
Infectious Disease Associates
Sarasota, Florida, 34239, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Tufts University School of Medicine
Boston, Massachusetts, 02111, United States
Community Research Initiative of New England
Boston, Massachusetts, 02215, United States
Community Research Initiative Of New England
Springfield, Massachusetts, 01107, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Albany Medical College
Albany, New York, 12208, United States
Weill Medical College of Cornell Universtiy
New York, New York, 10021, United States
St. Luke's Roosevelt Hospital
New York, New York, 10025, United States
Bronx Women's Interagency HIV Study
The Bronx, New York, 10467, United States
Central Texas Clincial research
Austin, Texas, 78705, United States
IDP Research
Annandale, Virginia, 22003, United States
Office of Daniel Coulston, M.D.
Spokane, Washington, 99204, United States
AIDS Research Program
Vancouver, British Columbia, V6Z 1Y6, Canada
Primary Completion
September 28, 2005
Actual (reported)Study Completion
September 28, 2005
Actual (reported)Last Updated
July 20, 2018
Results First Posted
July 20, 2018
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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