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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: Legacy Community Health Center; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Fenofibrate; Niacin; Niacinamide; Nicotinic Acids

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