Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels
This study is a pilot study examining the effect of extended-release niacin (Niaspan ®) on flow-mediated vasodilation (FMD) of the brachial artery, among human immunodeficiency virus (HIV)-1 infected individuals with low high density lipoprotein (HDL). Brachial artery diameter will be measured by high-resolution ultrasound at entry and week 12 of study. The primary comparisons will be change in FMD from baseline to 12 weeks within each of the two arms. The second specific aim will be to investigate the proportion of the effect of extended-release niacin on other known cardiovascular markers.
Drug: extended release niacin
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Pilot Study of the Effect of Niaspan on Endothelial Function in HIV-infected Subjects With Low HDL Cholesterol Levels|
- Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12 [ Time Frame: Two time points (baseline and study week 12) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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|