Status:
COMPLETED
Study of Niacin on Endothelial Function in HIV-infected Subjects With Low High Density Lipoprotein Cholesterol Levels
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
United States Department of Defense
Conditions:
HIV Infections
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Low high density lipoprotein (HDL) and a lipid pattern consistent with atherogenic dyslipidemia are also common in the human immunodeficiency virus (HIV)infected population and is likely due, in large...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00986986
Start Date
November 1 2007
End Date
April 1 2010
Last Update
December 18 2012
Active Locations (1)
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1
University of Hawaii - Hawaii Center for AIDS
Honolulu, Hawaii, United States, 96816