N/A Completed N=20 Randomized Treatment

Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels

HIV · Dyslipidemia · Endothelial Dysfunction

Source: ClinicalTrials.gov NCT00986986 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2012

Primary outcomePrimary: Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12 — 6.36; 2.73 percentage change in FMD

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12	6.36; 2.73	—
PRIMARY Flow Mediated Vasodilation	4.51; 3.25	—
SECONDARY High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12	42.0; 27.0	—
SECONDARY HDL	—	—

Eligibility Criteria

Inclusion Criteria

Age ≥18 years
Documented HIV infection
Subjects must have taken HAART 6 months prior to study entry and must be on stable HAART (no dose change to antiretroviral medications) for at least 30 days immediately prior to study entry
HDL 2.5 x upper limit of normal (ULN)
Creatinine >1.5 x ULN
Individuals with an infection or other medical illness requiring hospitalization within 14 days prior to study entry
Individuals who have active alcohol or drug abuse which, in the investigator's opinion, is sufficient to prevent adequate compliance with study therapy and evaluations
Prior history of hypersensitivity reaction to niacin or any other component of the study drug

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00986986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.