LONG-TERM PHYSIOLOGIC EFFECTS OF GH IN HIV LIPODYSTROPHY

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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 purpose of the study is to evaluate the effects of giving growth hormone to men and women with HIV and changes in fat distribution (the HIV lipodystrophy syndrome). Growth hormone levels are reduced in patients with HIV lipodystrophy, and this may result in increased abdominal fat, decreased bone density, increased risk of cardiovascular disease and decreased insulin sensitivity. Prior studies in non-HIV infected patients with growth hormone deficiency have shown that low dose growth hormone improves body composition and bone density, as well as decreasing the risk of cardiovascular disease. In this study, the relationship between growth hormone levels and bone formation, body composition, cardiovascular risk and insulin sensitivity will be investigated. A target of sixty subjects who meet the entrance criteria of the study (stimulated GH <7.5 mcg/dL, evidence of lipodystrophy, no history of diabetes) will be enrolled in this study for three years, with a total of 18 visits: the screening visit, ten one-hour visits, and seven day-long visits. Both male and female subjects will be enrolled. Participants will self-inject growth hormone for 18 months and placebo (contains no active ingredients) for 18 months.