Conditions: Lipodystrophy HIV Infections
Keywords: HIV Lipodystrophy Abdominal fat accumulation Growth hormone releasing hormone HIV-associated lipodystrophy Treatment experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 263
Healthy volunteers: no

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.

Arms:
arm 1: Tesamorelin 2 mg/day for 12 months arm 2: Tesamorelin 2 mg/day for 6 months - Placebo for 6 months arm 3: Placebo 6 months - Tesamorelin 2 mg/day for 6 months

Interventions: intervention 1: Tesamorelin intervention 2: Placebo for Tesamorelin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: