HIV Clinical Trial
Official title:
ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART
HIV-infected patients are at increased risk for cardiovascular disease. Large investigations
support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a
treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only
through its benefit in terms of lipid profile, but also by reducing atherosclerotic
inflammation.
The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on
suppressive cART has the potential for reducing subclinical atherosclerotic inflammation
associated with HIV itself in HIV-individuals on cART.
NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test
the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT)
in 90 subjects.
- Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5
to the end of the study (the titration aims to reduce adverse reactions)
- Regimen 2: ER niacin/laropiprant placebo p.m.
The primary end point is the change in mean common carotid intima-media thickness from
baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.
The proposed in vivo experiments should provide insights on the potential benefits of niacin
treatment of cardiovascular disease in HIV patients. In addition, we will be able to further
clarify the role of systemic inflammatory mediators in the development of early
atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment
of non-infectious co-morbidities such as cardiovascular diseases have become essential for
HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere
management of opportunistic infections or virologic suppression.
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