Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels
|ClinicalTrials.gov Identifier: NCT00986986|
Recruitment Status : Completed
First Posted : September 30, 2009
Results First Posted : December 18, 2012
Last Update Posted : December 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Dyslipidemia Endothelial Dysfunction||Drug: extended release niacin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Pilot Study of the Effect of Niaspan on Endothelial Function in HIV-infected Subjects With Low HDL Cholesterol Levels|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Active Drug (extended release niacin)
Subjects in this arm will be given 12 weeks of extended release niacin. Intervention: extended release niacin (Niaspan) starting at 500 mg by mouth daily and titrated to a maximum dose of 1500 mg by mouth daily. Titration will depend on patient tolerability.
Drug: extended release niacin
Active arm subjects will start extended release niacin (Niaspan) at 500 mg per night (by mouth once a daily) and titrate to a maximum tolerated dose (not exceeding 1500 mg per night (by mouth once a day) for 12 weeks. Titration will depend on patient tolerability of Niaspan.
Other Name: Niaspan
No Intervention: Observation
Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
- Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12 [ Time Frame: Two time points (baseline and study week 12) ]Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.
- Flow Mediated Vasodilation [ Time Frame: 12 weeks ]Flow mediated vasodilation is a marker of endothelial function
- High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12 [ Time Frame: Two time points (baseline and study week 12) ]HDL, often referred to "Good cholesterol levels", will be obtained in both arms. HDL is a marker of coronary heart disease.
- HDL [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986986
|United States, Hawaii|
|University of Hawaii - Hawaii Center for AIDS|
|Honolulu, Hawaii, United States, 96816|
|Principal Investigator:||Dominic C Chow, MD||University of Hawaii - Hawaii Center for AIDS|