ASSESSING THE SAFETY AND EFFICACY OF A 2MG DOSE OF TH9507, A GROWTH HORMONE RELE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary goal of the stduy is to determine the safety and efficacy of the medication TH9507, a growth hormone releasing factor, in reducing excess visceral adiposity associated with HIV lipodystrophy. Secondary objectives include improvements in total cholesterol/HDL ratio, triglyceride levels, changes in IGF-1 and improvement in quality of life and characterization of the safety profile of TH9507 treatment in HIV subjects with excess abdominal fat accumulation. HIV infected patients treated with antiretroviral therapy commonly exhibit body composition changes and metabolic abnormalities, termed the HIV lipodystrophy syndrome. Increased visceral adiposity has been associated with abnormal lipid profiles, hyperinsulinemia and impaired glucose tolerance in this population. Reduced growth hormone levels have been implicated as a potential link between abdominal obesity and metabolic disturbances.