TH9507 in Patients With HIV-Associated Lipodystrophy
A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation
1 other identifier
interventional
412
2 countries
42
Brief Summary
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Jun 2005
Shorter than P25 for phase_3 hiv-infections
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedNovember 27, 2013
November 1, 2013
1.4 years
July 20, 2005
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visceral adipose tissue (VAT)
Interventions
Eligibility Criteria
You may qualify if:
- Ages 18 to 65 years inclusive
- 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
You may not qualify if:
- Body mass index \< 20 kg/m2
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
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
Related Publications (5)
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: 28832410DERIVEDStanley 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: 22495074DERIVEDFalutz 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: 20554713DERIVEDFalutz 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.
PMID: 20101189DERIVEDFalutz 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.
PMID: 18057338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Grinspoon, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
June 1, 2005
Primary Completion
November 1, 2006
Study Completion
April 1, 2007
Last Updated
November 27, 2013
Record last verified: 2013-11