Clinical Trial: TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Growth Hormone Releasing Factor Analog, in HIV Subje

Brief Summary: 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.

Detailed Summary:
Sponsor: Theratechnologies

Current Primary Outcome:

  • Changes From Baseline in Fasting Blood Glucose at Week 52 [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Visceral adipose tissue (VAT)

Current Secondary Outcome: Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 [ Time Frame: 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.


Original Secondary Outcome: Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image

Information By: Theratechnologies

Dates:
Date Received: January 23, 2008
Date Started: August 2007
Date Completion:
Last Updated: March 27, 2014
Last Verified: March 2014