TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Registered clinical trial record on ClinicalTrials.gov (NCT00608023). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results, though the sponsor has posted summary results. Status: completed. Study type: interventional. Phase: Phase 3. Sponsor: Theratechnologies. Conditions: Lipodystrophy, HIV Infections. Interventions: Tesamorelin, Placebo for Tesamorelin. 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 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. Primary outcome measures: Changes From Baseline in Fasting Blood Glucose at Week 52; Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52. 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.