TH9507 in Patients With HIV-Associated Lipodystrophy
Status:
Completed
Trial end date:
2007-04-01
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 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.