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NCT00608023 Clinical Trial

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

HIV Infections Clinical Trial

Official title:
A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00608023
Other study ID # TH9507-CTR-1012
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2007
Est. completion date October 2008

Study information
Verified date September 2022
Source Theratechnologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Completed
Enrollment 263
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tesamorelin

• Placebo for Tesamorelin

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

Sponsors (1)
Lead Sponsor Collaborator
Theratechnologies

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Other Changes From Baseline in Triglycerides at Week 52 Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported. Baseline and Week 52
Other Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported. Baseline and Week 52
Primary Changes From Baseline in Fasting Blood Glucose at Week 52 Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported. Baseline and Week 52
Primary Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at 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. Baseline and Week 52
Secondary Changes From Baseline in Visceral Adipose Tissue (VAT) at 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. Baseline and Week 52
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