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

February 25, 2016 updated by: Ashok Balasubramanyam, Baylor College of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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
Other: Placebos
Placebos for Niaspan and Tricor
Behavioral: Diet
ATP-III diet
Behavioral: Exercise
Supervised exercise in study gym
EXPERIMENTAL: 3
Diet, exercise, Niaspan, and placebo
Other: Placebos
Placebos for 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
EXPERIMENTAL: 4
Diet, exercise, placebo, and Tricor
Other: Placebos
Placebos for Niaspan and Tricor
Behavioral: Diet
ATP-III diet
Behavioral: Exercise
Supervised exercise in study gym
Drug: Fenofibrate
Tricor, 120 mg per day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triglycerides
Time Frame: Measured at 24 weeks
Triglycerides (mg/dL): Fasting lipid levels
Measured at 24 weeks
Non-HDL-C
Time Frame: Measured at 24 weeks
non-HDL-C (mg/dL): Fasting lipid levels
Measured at 24 weeks
HDL-C
Time Frame: Measured at 24 weeks
HDL-C (mg/dL): Fasting lipid levels
Measured at 24 weeks
Total Cholesterol
Time Frame: Measured at 24 weeks
Total cholesterol (mg/dL): Fasting lipid levels
Measured at 24 weeks
Total Cholesterol : HDL-C Ratio
Time Frame: Measured at 24 weeks
Total cholesterol : HDL-C ratio: Fasting lipid levels
Measured at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity
Time Frame: Measured at 24 weeks
Adiponectin (micrograms/ml)
Measured at 24 weeks
Body Composition
Time Frame: Measured at 24 weeks
  1. Body cell mass (kg)
  2. Fat mass (kg)
Measured at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Legacy Community Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

October 27, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (ESTIMATE)

October 30, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-14105
  • R01HL073696 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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