TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Phase 3

Completed

Conditions: HIV Infections
Lipodystrophy

Interventions: Drug: Tesamorelin
Drug: Placebo for Tesamorelin

Registration Number: NCT00608023

Lead Sponsor: Theratechnologies

Brief Summary: 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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 263

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-Tesamorelin (P-T)	Placebo for Tesamorelin	Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Tesamorelin-Placebo (T-P)	Placebo for Tesamorelin	Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Tesamorelin-Placebo (T-P)	Tesamorelin	Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Tesamorelin 12 months (T-T)	Tesamorelin	Tesamorelin 2 mg/day for 12 months
Placebo-Tesamorelin (P-T)	Tesamorelin	Placebo 6 months - Tesamorelin 2 mg/day for 6 months

Primary Outcome Measures

Name	Time	Method
Changes From Baseline in Fasting Blood Glucose at Week 52	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	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 Outcome Measures

Name	Time	Method
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52	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.

Trial Locations

Locations (47): Somero, Michael
🇺🇸
Indio, California, United States
Office of Dr. Michael Somero
🇺🇸
Palm Springs, California, United States
AIDS Research Alliance
🇺🇸
West Hollywood, California, United States
Hendry/Glades County Health Departments
🇺🇸
LaBelle, Florida, United States
Infectious Disease Research Institute Inc.
🇺🇸
Tampa, Florida, United States
Tufts University School of Medicine
🇺🇸
Boston, Massachusetts, United States
The Research Institute
🇺🇸
Springfield, Massachusetts, United States
AIDS Community Research Initiative of America
🇺🇸
New York, New York, United States
Central Texas Clinical Research
🇺🇸
Austin, Texas, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
McMaster University Health Sciences Centre
🇨🇦
Hamilton, Ontario, Canada
Groupe de Recherche en Rhumatologie et maladies osseuses
🇨🇦
Ste-Foy, Quebec, Canada
Hôpital Hotel Dieu Lyon
🇫🇷
Lyon Cedex 69, France
Hopital Europeen Georges Pompidou
🇫🇷
Paris, France
Hopital Necker
🇫🇷
Paris, France
Hotel Dieu
🇫🇷
Nantes Cedex 1, France
Hosp. Clinico San Carlos
🇪🇸
Madrid, Spain
Hosp. Ramon y Cajal
🇪🇸
Madrid, Spain
Hosp.C.U.de Santiago
🇪🇸
Santiago de Compostela, Spain
BSUH NHS Trust
🇬🇧
Brighton, United Kingdom
Royal Free Hospital
🇬🇧
London, United Kingdom
St Georges Hospital
🇬🇧
London, United Kingdom
Chelsea and Westminster Hospital
🇬🇧
London, United Kingdom
St Mary's NHS Trust
🇬🇧
London, United Kingdom
UCLA School of Medicine
🇺🇸
Los Angeles, California, United States
AIDS Research Consortium Atlanta (ARCA)
🇺🇸
Atlanta, Georgia, United States
Office of Dr. Gary Richmond
🇺🇸
Fort Lauderdale, Florida, United States
Northern Healthcare
🇺🇸
Chicago, Illinois, United States
Northstar Medical
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University Hospitals of Cleveland
🇺🇸
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸
Dallas, Texas, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
Sunnybrook Health Sciences Centre
🇨🇦
Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
UCSF/VA Medical Center
🇺🇸
San Francisco, California, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
University of California
🇺🇸
San Francisco, California, United States
Kaiser Permanente
🇺🇸
San Francisco, California, United States
Denver Public Health Department
🇺🇸
Denver, Colorado, United States
Indiana University Department of Medicine
🇺🇸
Indianapolis, Indiana, United States
ID Associates
🇺🇸
Hillsborough, New Jersey, United States
Body Positive Inc.
🇺🇸
Phoenix, Arizona, United States
St-Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
C. H. U. Sart-Tilman
🇧🇪
Liège, Belgium
Centre Hospitalier Universitaire de Santé de l'Estrie
🇨🇦
Fleurimont, Quebec, Canada
Montreal General Hospital
🇨🇦
Montreal, Quebec, Canada