NCT00608023

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Theratechnologies · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lipodystrophy
• HIV Infections

Interventions

Type	Name	Description
DRUG	Tesamorelin
DRUG	Placebo for Tesamorelin

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-06
• Last updated: 2022-09-30
• Results posted: 2014-01-15

Locations

47 sites across 6 countries: United States, Belgium, Canada, France, Spain, United Kingdom