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

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ClinicalTrials.gov Identifier: NCT00246376
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Legacy Community Health Center
Information provided by (Responsible Party):
Ashok Balasubramanyam, Baylor College of Medicine

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases HIV Infections Hyperlipidemia Hypertriglyceridemia Insulin Resistance Atherosclerosis Behavioral: Diet Behavioral: Exercise Drug: Niacin Drug: Fenofibrate Other: Placebos Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy
Study Start Date : January 2004
Actual Primary Completion Date : September 2009
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: 1
Subjects receive lifestyle advice and placebos for Niaspan and Tricor
 Other: Placebos
Placebos for Niaspan and Tricor
Experimental: 2
Diet, exercise, and two placebos
 Behavioral: Diet
ATP-III diet
Behavioral: Exercise
Supervised exercise in study gym
Other: Placebos
Placebos for Niaspan and Tricor
Experimental: 3
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
Experimental: 4
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
Experimental: 5
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


Outcome Measures
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Primary Outcome Measures :
  1. Triglycerides [ Time Frame: Measured at 24 weeks ]
    Triglycerides (mg/dL): Fasting lipid levels

  2. Non-HDL-C [ Time Frame: Measured at 24 weeks ]
    non-HDL-C (mg/dL): Fasting lipid levels

  3. HDL-C [ Time Frame: Measured at 24 weeks ]
    HDL-C (mg/dL): Fasting lipid levels

  4. Total Cholesterol [ Time Frame: Measured at 24 weeks ]
    Total cholesterol (mg/dL): Fasting lipid levels

  5. Total Cholesterol : HDL-C Ratio [ Time Frame: Measured at 24 weeks ]
    Total cholesterol : HDL-C ratio: Fasting lipid levels


Secondary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: Measured at 24 weeks ]
    Adiponectin (micrograms/ml)

  2. Body Composition [ Time Frame: Measured at 24 weeks ]
    1. Body cell mass (kg)
    2. Fat mass (kg)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246376


Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77098
Sponsors and Collaborators
Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Legacy Community Health Center
Investigators
Principal Investigator: Ashok Balasubramanyam, MD Baylor College of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ashok Balasubramanyam, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00246376     History of Changes
Other Study ID Numbers: H-14105
R01HL073696 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2005    Key Record Dates
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
HIV Infections
Cardiovascular Diseases
Heart Diseases
Insulin Resistance
Atherosclerosis
Hyperlipidemias
Hyperlipoproteinemias
Hypertriglyceridemia
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Skin Diseases, Metabolic
Skin Diseases
Fenofibrate
Niacin
Niacinamide