Sponsor study identifier
Secondary identifiers
OTHER_GRANT · 06187003
interventional
20
1 country
1
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 29, 2009
Actual (reported)September 30, 2009
Actual (reported)April 2010
Actual (reported)April 2010
Actual (reported)December 18, 2012
Actual (reported)Change in Flow-mediated Vasodilation (FMD) From Baseline to 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.
Two time points (baseline and study week 12)
Flow Mediated Vasodilation
Flow mediated vasodilation is a marker of endothelial function
12 weeks
High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12
Two time points (baseline and study week 12)
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.
Subjects in this arm will be monitored for 12 weeks and will not receive 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.
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, 96816, United States
Chow DC, Stein JH, Seto TB, Mitchell C, Sriratanaviriyakul N, Grandinetti A, Gerschenson M, Shiramizu B, Souza S, Shikuma C. Short-term effects of extended-release niacin on endothelial function in HIV-infected patients on stable antiretroviral therapy. AIDS. 2010 Apr 24;24(7):1019-23. doi: 10.1097/QAD.0b013e3283383016.
* Small sample size * Un-blinded pilot study * Increase in HDL was less than predicted in a non-HIV infected population
Dominic C Chow, MD
University of Hawaii - Hawaii Center for AIDS
20 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
HDL
12 weeks
Contact the study team to confirm eligibility.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)Last Updated
December 18, 2012
Results First Posted
December 18, 2012
Record last verified: 2012-07
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Source: ClinicalTrials.gov.
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