Clinical trial NCT00246376
Conditions: Cardiovascular Diseases Heart Diseases HIV Infections Hyperlipidemia Hypertriglyceridemia Insulin Resistance Atherosclerosis
Sponsor: Baylor College of Medicine
Start date: 2004-01-01; Completion date: 2012-02-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Subjects receive lifestyle advice and placebos for Niaspan and Tricor arm 2: Diet, exercise, and two placebos arm 3: Diet, exercise, Niaspan, and placebo arm 4: Diet, exercise, placebo, and Tricor arm 5: Diet, exercise, Niaspan, and Tricor
Interventions: intervention 1: Diet intervention 2: Exercise intervention 3: Niacin intervention 4: Fenofibrate intervention 5: Placebos
Intervention descriptions: intervention 1: ATP-III diet intervention 2: Supervised exercise in study gym intervention 3: Niaspan, titrated up to 2 grams per day intervention 4: Tricor, 120 mg per day intervention 5: Placebos for Niaspan and Tricor

Protocol documents: