This study is for HIV-infected people who have low levels of high-density lipoprotein cholesterol (HDL-C) and elevated triglycerides. This study will randomize participants to receive an HDL-C raising medication, either extended-release niacin or fenofibrate, for 24 weeks.

Objectives

The main purpose of this study is to see if taking either extended-release niacin or fenofibrate will help blood vessels work better by improving endothelial function and increasing HDL cholesterol.

Cholesterol is a soft, waxy substance found in all parts of the body, and triglycerides are a type of fat in your blood. HDL-C is a type of “good” cholesterol. People with low HDL-C have a higher risk of heart disease and may have problems with how their blood vessels relax.

“Endothelial function” refers to how well the endothelium, the inner lining of blood vessels, is working. When your endothelium is not working properly, the blood vessels have trouble expanding properly, which contributes to the development of heart and blood vessel disease.

This study will also help determine how safe extended-release niacin and fenofibrate are.

Eligibility Requirements

To participate in this study, you must be:

• HIV-1 infected men and women age at least 18 years old
• Currently on anti-HIV medications for at least 48 weeks
• HIV viral load level is undetectable
• CD4+ cell count is greater than or equal to 100
• HDL-cholesterol ≤ 40 mg/dL for men or ≤ 50 mg/dL for women
• Fasting triglycerides: 200-800 mg/dL
• LDL-cholesterol is less than 160 mg/dL
• Not currently taking lipid-lowering agents, and not planning to start
• Not on a high dose of fish oil (doses above 1000 mg daily), niacin, vitamin E or C
• No history of heart disease, diabetes, or untreated hypertension

Study Details

Participants will be assigned by chance (like flipping a coin) in a one to one ratio to either:

• Arm A: Extended-release niacin by mouth once daily (taken with aspirin)
• Arm B: Fenofibrate by mouth once daily.

Niacin, fenofibrate, and aspirin will be provided by the study.

Ultrasounds will be done to measure blood vessel changes at entry, 12, and 24 weeks.

Duration

Participants will receive treatment and be followed for 24 weeks.

For more information, contact Jacki Granholm at 919-668-1577.