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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Hawaii
• Collaborator: United States Department of Defense
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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