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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Extended-release niacin will be given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24.
Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks.
Alabama Therapeutics CRS (5801)
Birmingham, Alabama, United States
University of Southern California (1201)
Los Angeles, California, United States
UCLA CARE Center CRS (601)
Los Angeles, California, United States
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, United States
University of Colorado Hospital CRS (6101)
Aurora, Colorado, United States
Northwestern University CRS (2701)
Chicago, Illinois, United States
New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)
Newark, New Jersey, United States
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS (1601)
Durham, North Carolina, United States
...and 4 more locations
Absolute Change in Relative FMD (%)
The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.
Time frame: 0 and 24 weeks
Change in Cholesterol
Absolute change in total cholesterol from week 0 to week 24.
Time frame: 0 and 24 weeks
Change in Triglycerides
Change in Triglycerides (mg/dL) from week 0 to week 24.
Time frame: 0 and 24 weeks
Men: Change in HDL Cholesterol
Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.
Time frame: 0 and 24 weeks
Women: Change in HDL Cholesterol
Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.
Time frame: 0 and 24 weeks
Change in HDL Particles
Change in total HDL particles from week 0 to week 24
Time frame: 0 and 24 weeks
Change in Non-HDL Cholesterol
Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.
Time frame: 0 and 24 weeks
Change in LDL Cholesterol
Change in LDL cholesterol (mg/dL) from week 0 to week 24.
Time frame: 0 and 24 weeks
Change in Small LDL Particles
Change in Small LDL particles from week 0 to week 24.
Time frame: 0 and 24 weeks
Change in Large HDL Particles
Change in Large HDL Particles from week 0 to week 24
Time frame: 0 and 24 weeks
Change in HOMA-IR
Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR
Time frame: 0 and 24 weeks
Change in IL-6
Change in IL-6 from week 0 to week 24
Time frame: 0 and 24 weeks
Change in C-reactive Protein (CRP)
Change in C-reactive protein from week 0 to week 24.
Time frame: 0 and 24 weeks
Change in D-Dimer
Change in D-Dimer from week 0 to week 24
Time frame: 0 and 24 weeks
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