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
1 other identifier
interventional
326
2 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started May 2004
Shorter than P25 for phase_3 hiv-infections
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2004
CompletedFirst Posted
Study publicly available on registry
May 17, 2004
CompletedStudy Start
First participant enrolled
May 28, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2005
CompletedResults Posted
Study results publicly available
July 20, 2018
CompletedJuly 20, 2018
September 1, 2017
1.3 years
May 13, 2004
October 2, 2017
October 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
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
Study Arms (5)
Period I: Placebo
PLACEBO COMPARATORSubjects will receive placebo matched to serostim® as subcutaneous injection daily for a period of 12 weeks.
Period I: Serostim® 4 mg
EXPERIMENTALSubjects 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.
Period II: Serostim® 4 mg to Placebo
EXPERIMENTALAll 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.
Period II: Serostim® 4 mg to Serostim® 2 mg
EXPERIMENTALAll 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.
Period II: Placebo to Placebo/Serostim® 4 mg
EXPERIMENTALAll 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.
Interventions
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.
Serostim® 2 mg as subcutaneous injection on alternate days.
Eligibility Criteria
You may qualify if:
- Have written laboratory documentation of an HIV infection by one of the following methods:
- Detectable viral load measured by polymerase chain reaction (PCR) amplification, branched chain DNA (bDNA) signal amplification or the presence of p24 antigen.
- Presence of HIV antibodies confirmed by either Western blot or immunofluorescence assay.
- Written laboratory documentation of an HIV infection must be obtained prior to randomization. In the absence of documented historical confirmation, an assay of HIV antibodies will be included in the Screening Laboratory Panel. Results will be confirmed with a Western Blot.
- Have evidence of excess abdominal adipose deposition when measured by the anthropometric methodology, using the following cut off values:
- Men: Waist circumference \>88.2 cm AND waist: hip ratio \>= 0.95.
- Women: Waist circumference \>75.3 cm AND waist: hip ratio \>= 0.9.
- Are taking antiretroviral medication(s) which is (are) approved or is (are) available under a Treatment IND. The regimen must have remained stable for 30 days prior to study entry. Subjects must also agree not to discontinue or to change their regimen for the duration of the study except as judged medically necessary.
- Have parameter values less than the following limits (using results from the central laboratory):
- AST, ALT, and amylase \<= 3 times the upper limit of normal (Screening).
- Fasting triglycerides \<= 1,000 mg/dL (Screening).
- Fasting glucose \<110 mg/dL (Screening).
- Two-hour (120 minute) glucose \<140 mg/dL (Screening).
- Weight \>= 36 kg (79.3 lb)
- Be between 18 and 60 years of age (inclusive) unless local law dictates different limits.
- +12 more criteria
You may not qualify if:
- Have an active AIDS-defining opportunistic complication (OC) as defined by the CDC or have had an untreated or suspected serious systemic infection, or have had a persistent fever \>= 101°F (38.3°C) during the 30 days prior to study entry.
- Any active or past history of malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy). Such exceptions must be confirmed in writing by the Serono Study Director.
- Have a CNS mass or active CNS process associated with neurological findings.
- Have unstable or untreated hypertension, defined as \>= 140/90 mm Hg at the time of the Screening Visit, and/or have initiated or changed antihypertensive therapy in the 30 days prior to Study Day 1.
- Have an acute critical illness treated in an intensive care unit, e.g., due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
- Have a recent history of sleep apnea or intermittent upper respiratory obstruction.
- Have any condition, which interferes with informed consent or protocol compliance including, but not limited to, active substance abuse and/or dementia.
- Are unable to comply with the Concomitant Therapy restrictions including:
- therapy for obesity including therapy with anorexigenic or fat reducing drugs
- anti-diabetic or insulin sensitizing medications
- systemic glucocorticoids
- systemic chemotherapy, interferon or radiation therapy treatment
- progestational agents, unless used for oral contraception or post-menopausal hormone replacement therapy
- appetite stimulants
- investigational agents, unless approved in advance by the study medical director. Specifically, experimental antiretroviral agents are disallowed, unless available under a treatment IND or expanded access program (30 days).
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (31)
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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2004
First Posted
May 17, 2004
Study Start
May 28, 2004
Primary Completion
September 28, 2005
Study Completion
September 28, 2005
Last Updated
July 20, 2018
Results First Posted
July 20, 2018
Record last verified: 2017-09