TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT ID: NCT00608023
Last Updated: 2022-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
263 participants
INTERVENTIONAL
2007-08-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
Tesamorelin
Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Tesamorelin
Placebo for Tesamorelin
Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Tesamorelin
Placebo for Tesamorelin
Interventions
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Tesamorelin
Placebo for Tesamorelin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent before any trial-related activities.
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Theratechnologies
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Grinspoon, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Central Texas Clinical Research
Austin, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
C. H. U. Sart-Tilman
Liège, , Belgium
St-Paul's Hospital
Vancouver, British Columbia, Canada
McMaster University Health Sciences Centre
Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Santé de l'Estrie
Fleurimont, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Groupe de Recherche en Rhumatologie et maladies osseuses
Ste-Foy, Quebec, Canada
Hôpital Hotel Dieu Lyon
Lyon, , France
Hotel Dieu
Nantes, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Necker
Paris, , France
Hosp. Ramon y Cajal
Madrid, , Spain
Hosp. Clinico San Carlos
Madrid, , Spain
Hosp.C.U.de Santiago
Santiago de Compostela, , Spain
BSUH NHS Trust
Brighton, , United Kingdom
St Georges Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
St Mary's NHS Trust
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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TH9507-CTR-1012
Identifier Type: -
Identifier Source: org_study_id
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