HIV Infections Clinical Trial
Official title:
Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.
BACKGROUND:
HIV lipodystrophy syndrome is associated with both metabolic (e.g., dyslipidemia and insulin
resistance) and anthropomorphic (e.g., lipoatrophy and central obesity) abnormalities. These
defects are likely to predispose HIV patients on highly active antiretroviral therapy
(HAART) to accelerated cardiovascular morbidity. Based on studies of key mechanisms of
altered lipid kinetics in these patients, evidence that DE patterns of patients with HIV
lipodystrophy are inadequate to manage cardiovascular risk factors, and current
recommendations for treatment of atherosclerosis and insulin resistance, the following is
hypothesized: 1) an intensive lifestyle intervention with DE will improve the plasma lipid
profile, decrease visceral fat mass, and improve hormonal, metabolic, and lipoprotein
markers associated with insulin resistance; and 2) adding niacin, fenofibrate, or a
combination of the two drugs to the intensive lifestyle intervention will result in further
improvement in the cardiovascular risk profile.
DESIGN NARRATIVE:
This randomized, placebo-controlled study of 200 hypertriglyceridemic HIV patients on stable
HAART treatment has the following specific aims: 1) to compare the effects of usual care,
intensive DE, DE plus niacin, DE plus fenofibrate, and DE plus niacin plus fenofibrate on
fasting plasma lipid concentrations (primary endpoint); 2) to compare the effects of the
five treatment protocols on body fat distribution; and 3) to compare the effects of the five
treatment protocols on hormonal, lipoprotein, and metabolic markers of insulin resistance.
The collaborative team has expertise in lipid and lipoprotein metabolism, innovative and
effective diet modification programs, intensive exercise programs in HIV patients, and
studies of antilipidemic and antiretroviral agents. Therefore, this study will determine the
efficacy of DE, with and without niacin and fenofibrate, in reducing the cardiovascular risk
of patients with HIV lipodystrophy or dyslipidemia.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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