Brief Title
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Changes From Baseline in Fasting Blood Glucose at Week 52
Secondary Outcome
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Condition
Lipodystrophy
Intervention
Tesamorelin
Study Arms / Comparison Groups
Tesamorelin 12 months (T-T)
Description: Tesamorelin 2 mg/day for 12 months
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
263
Start Date
August 2007
Completion Date
October 2008
Primary Completion Date
October 2008
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Steven Grinspoon, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00608023
Organization ID
TH9507-CTR-1012
Responsible Party
Sponsor
Study Sponsor
Theratechnologies
Study Sponsor
Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
Verification Date
September 2022