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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
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
HIV Infections Dyslipidemia Endothelial Dysfunction Drug: extended release niacin

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2007
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Flow Mediated Vasodilation [ Time Frame: 12 weeks ]
    Flow mediated vasodilation is a marker of endothelial function

Secondary Outcome Measures :
  1. 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.

  2. HDL [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 < 40 mg/dL • LDL < 130 mg/dL
  • All subjects with reproductive potential should utilize adequate contraception for the duration of this study and for at least 12 weeks following permanent discontinuation of study treatment. Acceptable methods include male condom, female condom, diaphragm, or intra-uterine device (IUD)

Exclusion Criteria:

  • Known cardiac disease
  • Arrhythmia
  • History of angina
  • Uncontrolled hypertension
  • Pregnancy
  • Breast-feeding
  • Medication known to influence vasodilatation such as nitrates, metformin, pioglitazone, and rosiglitazone
  • Heavy use of vitamin supplements
  • Diagnosis of diabetes mellitus
  • Treatment with lipid-lowering drugs within 6 weeks prior to study
  • Hemoglobin <9.0 mg/dL
  • Absolute neutrophil count <750 cells/mm3
  • Platelet count <75,000 platelets/ mm3
  • Alanine aminotransferase (ALT or SGOT)/ aspartate aminotransferase (AST or SGPT) / alkaline phosphatase > 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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
University of Hawaii
United States Department of Defense
Principal Investigator: Dominic C Chow, MD University of Hawaii - Hawaii Center for AIDS
More Information

Responsible Party: Dominic Chow, Associate Professor of Medicine and Pediatrics, University of Hawaii
ClinicalTrials.gov Identifier: NCT00986986     History of Changes
Other Study ID Numbers: ENDO
Department of Defense ( Other Grant/Funding Number: 06187003 )
First Posted: September 30, 2009    Key Record Dates
Results First Posted: December 18, 2012
Last Update Posted: December 18, 2012
Last Verified: July 2012

Keywords provided by Dominic Chow, University of Hawaii:
Human immunodeficiency virus
Low high density lipoprotein
Endothelial function
Flow-mediated vasodilation

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs