Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|