Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate
|ClinicalTrials.gov Identifier: NCT01426438|
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : October 21, 2014
Last Update Posted : February 3, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: Niacin Drug: Aspirin Drug: Fenofibrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of HDL-Raising Therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects With Low HDL Cholesterol: A Phase II Randomized Trial of Extended Release Niacin vs. Fenofibrate|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
|Experimental: Arm A: Extended-release niacin with aspirin||
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)Drug: Aspirin
Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24.
|Experimental: Arm B: Fenofibrate||
Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks.
- Absolute Change in Relative FMD (%) [ Time Frame: 0 and 24 weeks ]The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.
- Change in Cholesterol [ Time Frame: 0 and 24 weeks ]Absolute change in total cholesterol from week 0 to week 24.
- Change in Triglycerides [ Time Frame: 0 and 24 weeks ]Change in Triglycerides (mg/dL) from week 0 to week 24.
- Men: Change in HDL Cholesterol [ Time Frame: 0 and 24 weeks ]Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.
- Women: Change in HDL Cholesterol [ Time Frame: 0 and 24 weeks ]Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.
- Change in HDL Particles [ Time Frame: 0 and 24 weeks ]Change in total HDL particles from week 0 to week 24
- Change in Non-HDL Cholesterol [ Time Frame: 0 and 24 weeks ]Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.
- Change in LDL Cholesterol [ Time Frame: 0 and 24 weeks ]Change in LDL cholesterol (mg/dL) from week 0 to week 24.
- Change in Small LDL Particles [ Time Frame: 0 and 24 weeks ]Change in Small LDL particles from week 0 to week 24.
- Change in Large HDL Particles [ Time Frame: 0 and 24 weeks ]Change in Large HDL Particles from week 0 to week 24
- Change in HOMA-IR [ Time Frame: 0 and 24 weeks ]Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR
- Change in IL-6 [ Time Frame: 0 and 24 weeks ]Change in IL-6 from week 0 to week 24
- Change in C-reactive Protein (CRP) [ Time Frame: 0 and 24 weeks ]Change in C-reactive protein from week 0 to week 24.
- Change in D-Dimer [ Time Frame: 0 and 24 weeks ]Change in D-Dimer from week 0 to week 24
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426438
|United States, Alabama|
|Alabama Therapeutics CRS (5801)|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of Southern California (1201)|
|Los Angeles, California, United States, 90033-1079|
|UCLA CARE Center CRS (601)|
|Los Angeles, California, United States, 90095|
|Harbor-UCLA Med. Ctr. CRS (603)|
|Torrance, California, United States, 90502|
|United States, Colorado|
|University of Colorado Hospital CRS (6101)|
|Aurora, Colorado, United States, 80045|
|United States, Illinois|
|Northwestern University CRS (2701)|
|Chicago, Illinois, United States, 60611|
|United States, New Jersey|
|New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477)|
|Newark, New Jersey, United States, 07103|
|United States, New York|
|NY Univ. HIV/AIDS CRS (401)|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Unc Aids Crs (3201)|
|Chapel Hill, North Carolina, United States, 27516|
|Duke Univ. Med. Ctr. Adult CRS (1601)|
|Durham, North Carolina, United States, 27710|
|Moses H. Cone Memorial Hospital CRS (3203)|
|Greensboro, North Carolina, United States, 27401|
|United States, Ohio|
|Univ. of Cincinnati CRS (2401)|
|Cincinnati, Ohio, United States, 45267|
|Case CRS (2501)|
|Cleveland, Ohio, United States, 44106|
|United States, Washington|
|University of Washington AIDS CRS (1401)|
|Seattle, Washington, United States, 98104|
|Study Chair:||Michael P Dube, MD||University of Southern California|
|Study Chair:||James H Stein, MD||University of Wisconsin School of Medicine and Public Health (Northwestern University CRS)|