TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.