TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy
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.
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
The purpose of this observational, 10-year, prospective cohort study is to assess the
potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with
abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of
Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and
Type 2 diabetes mellitus (T2DM).
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