Conditions: AIDS HIV Infections
Keywords: HIV lipodystrophy growth hormone visceral fat IGF-I Treatment Experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

Detailed description:
This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.

Arms:
arm 1: recombinant human growth hormone subcutaneously once a day arm 2: placebo subcutaneously once a day

Interventions: intervention 1: recombinant human growth hormone intervention 2: placebo
Intervention descriptions: intervention 1: growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months intervention 2: placebo subcutaneously once a day, 18 months

Protocol document: