Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia (Heart Positive)

This study has been completed.
Sponsor:
Collaborator:
Legacy Community Health Center
Information provided by (Responsible Party):
Ashok Balasubramanyam, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00246376
First received: October 27, 2005
Last updated: April 25, 2012
Last verified: April 2012

October 27, 2005
April 25, 2012
January 2004
September 2009   (final data collection date for primary outcome measure)
Fasting serum triglyceride level [ Time Frame: Measured at 24 hours ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00246376 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity [ Time Frame: Measured at 24 hours ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: Measured at 24 hours ] [ Designated as safety issue: No ]
  • Lipoprotein fractions [ Time Frame: Measured at 4 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cardiovascular Diseases
  • Heart Diseases
  • HIV Infections
  • Hyperlipidemia
  • Hypertriglyceridemia
  • Insulin Resistance
  • Atherosclerosis
  • Behavioral: Diet
    ATP-III diet
  • Behavioral: Exercise
    Supervised exercise in study gym
  • Drug: Niacin
    Niaspan, titrated up to 2 grams per day
  • Drug: Fenofibrate
    Tricor, 120 mg per day
  • Other: Placebos
    Placebos for Niaspan and Tricor
  • Placebo Comparator: 1
    Subjects receive lifestyle advice and placebos for Niaspan and Tricor
    Intervention: Other: Placebos
  • Experimental: 2
    Diet, exercise, and two placebos
    Interventions:
    • Behavioral: Diet
    • Behavioral: Exercise
    • Other: Placebos
  • Experimental: 3
    Diet, exercise, Niaspan, and placebo
    Interventions:
    • Behavioral: Diet
    • Behavioral: Exercise
    • Drug: Niacin
    • Other: Placebos
  • Experimental: 4
    Diet, exercise, placebo, and Tricor
    Interventions:
    • Behavioral: Diet
    • Behavioral: Exercise
    • Drug: Fenofibrate
    • Other: Placebos
  • Experimental: 5
    Diet, exercise, Niaspan, and Tricor
    Interventions:
    • Behavioral: Diet
    • Behavioral: Exercise
    • Drug: Niacin
    • Drug: Fenofibrate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
February 2012
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive
  • On stable HAART regimen for at least 6 months prior to study entry
  • T-cell count greater than 100 and viral load less than 1,000 for at least 6 months prior to study entry
  • Fasting triglyceride level greater than 150 mg/dl
  • Body mass index (BMI) greater than 18.5 and less than 30
  • Uses barrier contraception

Exclusion Criteria:

  • Fasting triglyceride level greater than 1000 mg/dl
  • BMI less than 18.5 or greater than 30
  • Taking diabetic medication or HbA1c less than 7.0
  • Use of lipid lowering medication in the 30 days prior to study entry
  • Unable to exercise
  • T-cell count less than 100
  • Current medical condition that makes exercise unadvisable
  • History of coronary artery disease (CAD)
  • Use of dietary supplements (within 30 days of study entry) that may affect lipid levels including, but not limited to, the following:

    1. Omega-3 fatty acids
    2. L-Carnitine
    3. Soluble fiber supplements
    4. Guggul
    5. Garlic supplements
    6. Niacin greater than 25mg/d
    7. Oral liquid supplements
  • Use of steroids, hormones, or testosterone (without diagnosis of hypogonadism, testosterone less than 300 ng/dl)
  • Irregular periods
  • Depo-Provera
  • Hypo- or Hyperthyroidism
  • Adrenal insufficiency
  • Serum alanine or aspartate aminotransferase level greater than 3 times the upper limit of normal
  • Alcohol abuse
  • Renal insufficiency (creatinine level greater than 1.5 mg/dl)
  • Coumadin therapy
  • Pregnancy
  • Peptic ulcer disease
  • Cholelithiasis
  • History of hyperuricemia
  • History of myositis or rhabdomyolysis
  • Known adverse reaction to niacin or fibrates
  • Hepatitis C therapy
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00246376
340, R01 HL73696
Yes
Ashok Balasubramanyam, National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
Legacy Community Health Center
Principal Investigator: Ashok Balasubramanyam, MD Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP