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

NCT00986986 | Completed Results DMC

• 2 other identifiers: ENDODepartment of Defense
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Dyslipidemia; Endothelial Dysfunction

Keywords

Human immunodeficiency virus; Low high density lipoprotein; Endothelial function; Flow-mediated vasodilation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12

  Two time points (baseline and study week 12)

• HDL

  12 weeks

Study Arms (2)

Active Drug (extended release niacin)

EXPERIMENTAL

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

Observation

NO INTERVENTION

Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin

Interventions

extended release niacin DRUG

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.

Also known as: Niaspan

Active Drug (extended release niacin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Hawaii - Hawaii Center for AIDS

Honolulu, Hawaii, 96816, United States

Location

Related Publications (1)

• 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.

  PMID: 20216298 RESULT

MeSH Terms

Conditions

HIV Infections; Dyslipidemias; Acquired Immunodeficiency Syndrome

Interventions

Niacin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

* Small sample size * Un-blinded pilot study * Increase in HDL was less than predicted in a non-HIV infected population

Results Point of Contact

• Title: Dominic Chow
• Organization: University of Hawaii at Manoa

dominicc@hawaii.edu

(808)737-2751

Study Officials

• Dominic C Chow, MD

  University of Hawaii - Hawaii Center for AIDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Pediatrics

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 18, 2012
• Results First Posted: December 18, 2012

Record last verified: 2012-07

Locations

US (1)