Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborator:	Legacy Community Health Center
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00246376

Purpose

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.

Condition	Intervention
Cardiovascular Diseases Heart Diseases HIV Infections Hyperlipidemia Hypertriglyceridemia Insulin Resistance Atherosclerosis	Behavioral: Diet Behavioral: Exercise Drug: Niacin Drug: Fenofibrate Other: Placebos

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy

Resource links provided by NLM:

MedlinePlus related topics: AIDS Diets Exercise and Physical Fitness Heart Diseases Triglycerides

Drug Information available for: Niacin Procetofen Niacinamide Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Fasting serum triglyceride level [ Time Frame: Measured at 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	January 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Subjects receive lifestyle advice and placebos for Niaspan and Tricor	Other: Placebos Placebos for Niaspan and Tricor
2: Experimental Diet, exercise, and two placebos	Behavioral: Diet ATP-III diet Behavioral: Exercise Supervised exercise in study gym Other: Placebos Placebos for Niaspan and Tricor
3: Experimental Diet, exercise, Niaspan, and placebo	Behavioral: Diet ATP-III diet Behavioral: Exercise Supervised exercise in study gym Drug: Niacin Niaspan, titrated up to 2 grams per day Other: Placebos Placebos for Niaspan and Tricor
4: Experimental Diet, exercise, placebo, and Tricor	Behavioral: Diet ATP-III diet Behavioral: Exercise Supervised exercise in study gym Drug: Fenofibrate Tricor, 120 mg per day Other: Placebos Placebos for Niaspan and Tricor
5: Experimental Diet, exercise, Niaspan, and Tricor	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246376

Locations

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77098

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Legacy Community Health Center

Investigators

Principal Investigator:

Ashok Balasubramanyam, MD

Baylor College of Medicine

More Information

Publications:

Samson SL, Pownall HJ, Scott LW, Ballantyne CM, Smith EO, Sekhar RV, Balasubramanyam A. Heart positive: design of a randomized controlled clinical trial of intensive lifestyle intervention, niacin and fenofibrate for HIV lipodystrophy/dyslipidemia. Contemp Clin Trials. 2006 Dec;27(6):518-30. Epub 2006 Jul 21.

Responsible Party:	Baylor College of Medicine ( Ashok Balasubramanyam, MD )
Study ID Numbers:	340, R01 HL73696
Study First Received:	October 27, 2005
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00246376 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Vasodilator Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arteriosclerosis
Infection
Hyperinsulinism
Vitamins
Therapeutic Uses
Lipodystrophy
Cardiovascular Diseases
Micronutrients

Retroviridae Infections
Dyslipidemias
Arterial Occlusive Diseases
RNA Virus Infections
Vitamin B Complex
Hypertriglyceridemia
Hyperlipidemias
Heart Diseases
Metabolic Diseases
Skin Diseases
Immune System Diseases
Growth Substances
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Vascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010