Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia (Heart Positive)
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Diet/Exercise, Niacin, Fenofibrate for HIV Lipodystrophy |
- Fasting serum triglyceride level [ Time Frame: Measured at 24 hours ] [ Designated as safety issue: Yes ]
- 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 ]
| Enrollment: | 221 |
| Study Start Date: | January 2004 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 |
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:
- Omega-3 fatty acids
- L-Carnitine
- Soluble fiber supplements
- Guggul
- Garlic supplements
- Niacin greater than 25mg/d
- 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| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77098 | |
| Principal Investigator: | Ashok Balasubramanyam, MD | Baylor College of Medicine |
More Information
Publications:
| Responsible Party: | Ashok Balasubramanyam, Principal Investigator, National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00246376 History of Changes |
| Other Study ID Numbers: | 340, R01 HL73696 |
| Study First Received: | October 27, 2005 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Atherosclerosis Cardiovascular Diseases Heart Diseases Hyperlipidemias Hypertriglyceridemia Insulin Resistance Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hyperinsulinism Glucose Metabolism Disorders Skin Diseases, Metabolic Skin Diseases Niacin Fenofibrate |
ClinicalTrials.gov processed this record on March 03, 2013
