CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
extended release niacindrug
Likely dose
extended release niacin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00986986
NCT00986986N/ACompleted
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Prospective Randomized Pilot Study of the Effect of Niaspan on Endothelial Function in HIV-infected Subjects With Low HDL Cholesterol Levels

University of Hawaii·interventional·Posted Sep 30, 2009·Updated Dec 18, 2012

In Brief

A clinical study evaluating extended release niacin for HIV Infections and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Dyslipidemia, Endothelial Dysfunction
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2009
Enrollment StartNov 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.8 years ago

Interventions

extended release niacindrug

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.