HIV Infections Clinical Trial
Official title:
Anti-Lipolytic Strategy for HIV Lipodystrophy
The purpose of this study is to test whether chronic administration of the drug acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing highly active antiretroviral therapy (HAART) associated metabolic disturbances.
BACKGROUND:
HIV infected patients treated with HAART are at increased risk for developing significant
dyslipidemia, insulin resistance, and abnormal patterns of fat distribution. While the exact
mechanism responsible for these changes is not known, there is increasing evidence that
patients with HIV infection and fat redistribution have increased basal rates of lipolysis
and elevated circulating free fatty acids (FFA). Patients with HIV associated lipodystrophy
have increased FFA levels that correlated directly with impaired glucose metabolism and
triglyceride concentrations. Furthermore, acute inhibition of lipolysis in patients with HIV
lipodystrophy and insulin resistance results in improvement in insulin sensitivity. However,
long-term administration of lipolytic blocking agents has not been evaluated in this patient
population. Acipimox, a nicotinic acid analogue and a potent inhibitor of lipolysis, is an
established therapy for dyslipidemia. In addition, through effects on lowering circulating
FFA, acute administration of acipimox has been shown to improve insulin sensitivity in other
populations, including lean and obese individuals and patients with type II diabetes. This
study will test the hypothesis that chronic administration of acipimox will improve
hyperlipidemia and insulin sensitivity among HIV infected patients experiencing HAART
associated metabolic disturbances.
DESIGN NARRATIVE:
The study will be a 3-month double-blind placebo-controlled trial of 250 mg of acipimox
three times daily in 30 patients with HAART lipodystrophy. The primary clinical endpoint of
this study will be the change in fasting triglyceride concentration, comparing baseline
values to those obtained after 3 months of acipimox or placebo. Insulin sensitivity, an
important secondary endpoint, will be determined by hyperinsulinemic euglycemic clamp
studies. Rates of lipolysis in the fasting state will be quantified by a 3-hour infusion of
stable isotope-labeled glycerol. Indirect calorimetry will be used to assess changes in
resting energy expenditure. Cross-sectional computed tomography (CT) imaging of the thigh
and abdomen will allow for measurement of visceral and subcutaneous fat areas. Dual energy
x-ray absorptiometry (DEXA) will be used to determine whole body fat mass.
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Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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