Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
This study is being done with people with HIV infection who have low levels of HDL-C. 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. The endothelium is the inner lining
of all blood vessels, such as arteries and veins. When the endothelium is not working
properly, the blood vessels have trouble expanding properly, which contributes to the
development of heart and blood vessel disease.
The main purpose of this study is to see if taking either extended-release niacin or
fenofibrate for 24 weeks will help blood vessels work better by improving endothelial
function and increasing HDL-C. Niacin and fenofibrate are medications that raise HDL-C. This
study will also help determine how safe extended-release niacin and fenofibrate are.
The analysis is an as-treated analysis of participants who completed study treatment and had
a week 24 BART scan. Safety analyses include all participants
Phase:
Phase 2
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)