NCT00123253

TH9507 in Patients With HIV-Associated Lipodystrophy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Theratechnologies · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Lipodystrophy

Interventions

Type	Name	Description
DRUG	TH9507

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-11-01
• Completion: 2007-04-01
• First posted: 2005-07-22
• Last updated: 2013-11-27

Locations

42 sites across 2 countries: United States, Canada