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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dominic Chow, University of Hawaii
ClinicalTrials.gov Identifier:
NCT00986986
First received: September 29, 2009
Last updated: November 19, 2012
Last verified: July 2012
  Purpose

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 Intervention
HIV Infections
Dyslipidemia
Endothelial Dysfunction
Drug: extended release niacin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12 [ Time Frame: Two time points (baseline and study week 12) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Flow mediated vasodilation is a marker of endothelial function


Secondary Outcome Measures:
  • High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12 [ Time Frame: Two time points (baseline and study week 12) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 < 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986986

Locations
United States, Hawaii
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Dominic C Chow, MD University of Hawaii - Hawaii Center for AIDS
  More Information

Publications:
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
Study First Received: September 29, 2009
Results First Received: August 14, 2011
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Dyslipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014