Back to resultsTH9507 in Patients With HIV-Associated Lipodystrophy
Primary Purpose
HIV Infections, Lipodystrophy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TH9507
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing factor/Growth hormone releasing hormone, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Participation in a clinical trial with any investigational drug/device within 30 days of screening.
Sites / Locations
- UCLA School of Medicine
- Office of Dr. Michael Somero
- UCSD Medical Center
- Kaiser Permanente
- AIDS Research Alliance
- Capital Medical Associates
- Bach & Godofsky
- Office of Dr. Gary Richmond
- Care Resource Miami
- Orlando Immunology Center
- Infectious Disease Associates
- Treasure Coast Infectious Disease Consultant (TDIDC)
- AIDS Research Consortium Atlanta (ARCA)
- Northern Healthcare
- Rush University Medical Center
- Indiana University Department of Medicine
- Institute of Human Virology
- Johns Hopkins University School of Medicine
- Community Research Initiative of New England
- Massachusetts General Hospital
- Tufts University School of Medicine
- Community Research Initiative of New England (CRI West)
- Hennepin County Medical Centre
- AIDS Community Research Initiative of America
- Bellevue Hospital Center New York University
- St Luke's Roosevelt Hospital Centre
- St Vincent Catholic Medical Centre
- University of Cincinnati Medical Center
- Fanno Creek Clinic, LLC
- Drexel University College of Medicine
- Central Texas Clinical Research
- Dallas VA Medical Centre
- The University of Texas Medical School
- Infectious Disease Physicians Inc.
- Swedish Medical Center
- Southern Alberta Clinic
- St-Paul's Hospital
- Sunnybrook and Women College Health Sciences Centre
- Windsor Regional Hospital
- Clinique Médicale du Quartier Latin
- Clinique Médicale L'Actuel
- Montreal General Hospital
Outcomes
Primary Outcome Measures
Visceral adipose tissue (VAT)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00123253
Brief Title
TH9507 in Patients With HIV-Associated Lipodystrophy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Theratechnologies
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy
Keywords
HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing factor/Growth hormone releasing hormone, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TH9507
Primary Outcome Measure Information:
Title
Visceral adipose tissue (VAT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Participation in a clinical trial with any investigational drug/device within 30 days of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Grinspoon, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Office of Dr. Michael Somero
City
Palm Springs
State/Province
California
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
Country
United States
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
Country
United States
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
Country
United States
Facility Name
Capital Medical Associates
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Bach & Godofsky
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Office of Dr. Gary Richmond
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Care Resource Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Infectious Disease Associates
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultant (TDIDC)
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
AIDS Research Consortium Atlanta (ARCA)
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Northern Healthcare
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University Department of Medicine
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Institute of Human Virology
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Community Research Initiative of New England
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Community Research Initiative of New England (CRI West)
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Hennepin County Medical Centre
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
AIDS Community Research Initiative of America
City
New York
State/Province
New York
Country
United States
Facility Name
Bellevue Hospital Center New York University
City
New York
State/Province
New York
Country
United States
Facility Name
St Luke's Roosevelt Hospital Centre
City
New York
State/Province
New York
Country
United States
Facility Name
St Vincent Catholic Medical Centre
City
New York
State/Province
New York
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Fanno Creek Clinic, LLC
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
Country
United States
Facility Name
Dallas VA Medical Centre
City
Dallas
State/Province
Texas
Country
United States
Facility Name
The University of Texas Medical School
City
Houston
State/Province
Texas
Country
United States
Facility Name
Infectious Disease Physicians Inc.
City
Annandale
State/Province
Virginia
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Southern Alberta Clinic
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
St-Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Sunnybrook and Women College Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Windsor Regional Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Clinique Médicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Médicale L'Actuel
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28832410
Citation
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.
Results Reference
derived
PubMed Identifier
22495074
Citation
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.
Results Reference
derived
PubMed Identifier
20554713
Citation
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.
Results Reference
derived
PubMed Identifier
18057338
Citation
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.
Results Reference
derived
PubMed Identifier
20101189
Citation
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.
Results Reference
derived
Learn more about this trial
TH9507 in Patients With HIV-Associated Lipodystrophy
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