Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
Condition: Cardiovascular Diseases; Heart Diseases; HIV Infections; Hyperlipidemia; Hypertriglyceridemia; Insulin Resistance; Atherosclerosis
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Lipodystrophy; Insulin Resistance; Hyperlipidemias; Hypertriglyceridemia
Study type: Interventional

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.
    

Intervention name(s): Diet; Exercise; Niacin; Fenofibrate; Placebos
Intervention type(s): Behavioral; Behavioral; Drug; Drug; Other
Intervention description(s): ATP-III diet; Supervised exercise in study gym; Niaspan, titrated up to 2 grams per day; Tricor, 120 mg per day; Placebos for Niaspan and Tricor
Intervention MeSH terms: Niacin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment