Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
412 participants
INTERVENTIONAL
2005-06-30
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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TH9507
Eligibility Criteria
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Inclusion Criteria
* HIV positive; CD4 cell counts \>100 cells/mm3; viral load \<10,000 copies/mL (stable for 8 weeks)
* On stable ART regimen for at least 8 weeks prior to randomization
* Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:
* For males: waist circumference \> 95 cm and waist to hip ratio \> 0.94;
* For females: waist circumference \> 94 cm and waist to hip ratio \> 0.88.
* Females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study.
* Signed informed consent
Exclusion Criteria
* Opportunistic infection; HIV-related disease within 3 months of study.
* History of malignancy; active neoplasm.
* Prostate-specific antigen (PSA) \>5 ng/mL at screening
* Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis.
* Untreated hypothyroidism
* Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study
* ALT or AST \> 3 x ULN; serum creatinine \> 133 mmol/L (1.5 mg/dL); hemoglobin more than 20 g/L below LLN; fasting blood glucose \> 8.33 mmol/L (150 mg/dL); fasting triglycerides \> 11.3 mmol/L (0.99 g/dL).
* Untreated hypertension
* Change in anti-hyperlipemic regimen within 3 months prior to study
* Change in testosterone regimen and/or supraphysiological dose of testosterone
* Estrogen therapy
* Anoretics/anorexigenics or anti-obesity agents within 3 months of study
* Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products; IGF-1; or IGFBP-3 within 6 months of study.
* Drug or alcohol dependence or use of methadone within 6 months of study entry
* Participation in a clinical trial with any investigational drug/device within 30 days of screening.
18 Years
65 Years
ALL
No
Sponsors
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Theratechnologies
INDUSTRY
Principal Investigators
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Steven Grinspoon, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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UCLA School of Medicine
Los Angeles, California, United States
Office of Dr. Michael Somero
Palm Springs, California, United States
UCSD Medical Center
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
AIDS Research Alliance
West Hollywood, California, United States
Capital Medical Associates
Washington D.C., District of Columbia, United States
Bach & Godofsky
Bradenton, Florida, United States
Office of Dr. Gary Richmond
Fort Lauderdale, Florida, United States
Care Resource Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Infectious Disease Associates
Sarasota, Florida, United States
Treasure Coast Infectious Disease Consultant (TDIDC)
Vero Beach, Florida, United States
AIDS Research Consortium Atlanta (ARCA)
Atlanta, Georgia, United States
Northern Healthcare
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University Department of Medicine
Indianapolis, Indiana, United States
Institute of Human Virology
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
Community Research Initiative of New England (CRI West)
Springfield, Massachusetts, United States
Hennepin County Medical Centre
Minneapolis, Minnesota, United States
AIDS Community Research Initiative of America
New York, New York, United States
Bellevue Hospital Center New York University
New York, New York, United States
St Luke's Roosevelt Hospital Centre
New York, New York, United States
St Vincent Catholic Medical Centre
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Fanno Creek Clinic, LLC
Portland, Oregon, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Central Texas Clinical Research
Austin, Texas, United States
Dallas VA Medical Centre
Dallas, Texas, United States
The University of Texas Medical School
Houston, Texas, United States
Infectious Disease Physicians Inc.
Annandale, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Southern Alberta Clinic
Calgary, Alberta, Canada
St-Paul's Hospital
Vancouver, British Columbia, Canada
Sunnybrook and Women College Health Sciences Centre
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Clinique Médicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Médicale L'Actuel
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
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.
Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007 Dec 6;357(23):2359-70. doi: 10.1056/NEJMoa072375.
Other Identifiers
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TH9507/III/LIPO/010
Identifier Type: -
Identifier Source: org_study_id
NCT00435136
Identifier Type: -
Identifier Source: nct_alias