DRUG
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Status
Completed
Phase
Phase 3
Enrollment
263
Locations
47
Results
Posted
Publications
4
Study summary
What the protocol is testing.
Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
Full detailed description
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
Interventions
Treatment arms and agents.
DRUG
Placebo for Tesamorelin
Timeline
From registration to results.
First posted
Feb 6, 2008
Study start
Aug 2007
Primary completion
Oct 2008
Study completion
Oct 2008
Results posted
Jan 15, 2014
Registry updated
Sep 30, 2022
Outcomes
What the study measures.
Primary outcomes
Changes From Baseline in Fasting Blood Glucose at Week 52
Time frame · Baseline and Week 52
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Time frame · Baseline and Week 52
Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.
Secondary outcomes
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Time frame · Baseline and Week 52
Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study. * Signed informed consent before any trial-related activities. Exclusion Criteria: * Fasting blood glucose \>8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Study locations
47 registered sites.
Belgium · Canada · France · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Body Positive Inc.
Phoenix, Arizona, United States
Somero, Michael
Indio, California, United States
UCLA School of Medicine
Los Angeles, California, United States
Office of Dr. Michael Somero
Palm Springs, California, United States
University of California
San Francisco, California, United States
Kaiser Permanente
San Francisco, California, United States
UCSF/VA Medical Center
San Francisco, California, United States
AIDS Research Alliance
West Hollywood, California, United States
Denver Public Health Department
Denver, Colorado, United States
Office of Dr. Gary Richmond
Fort Lauderdale, Florida, United States
Hendry/Glades County Health Departments
LaBelle, Florida, United States
Infectious Disease Research Institute Inc.
Tampa, Florida, United States
AIDS Research Consortium Atlanta (ARCA)
Atlanta, Georgia, United States
Northern Healthcare
Chicago, Illinois, United States
Northstar Medical
Chicago, Illinois, United States
Indiana University Department of Medicine
Indianapolis, Indiana, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
ID Associates
Hillsborough, New Jersey, United States
AIDS Community Research Initiative of America
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Publications
Results and literature.
PMID 28832410 ↗Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.PMID 22495074 ↗Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.PMID 20554713 ↗Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.PMID 20101189 ↗Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.
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