Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular
inflammation, worsened endothelial function, and a predominance of non-calcified plaque.
These outcomes can be assessed using specialized noninvasive imaging which strongly predict
future CV events in the general population.
PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the
general population and recent studies among individuals without HIV have shown that PCSK9
inhibitor therapy is safely tolerated and significantly reduces major CV events in the
general population.
The investigators will perform a clinical trial of PCSK9 inhibition in the setting of HIV
infection. This will be a randomized, placebo-controlled study to evaluate the effects of
PCSK9 inhibition on vascular inflammation, endothelial function, and non-calcified plaque
using a PCSK9 inhibitor called alirocumab. This study will recruit 140 treated individuals
with HIV who are aged 40 and older, with known CVD or risk factors for CVD and who have
evidence of vascular inflammation at baseline.
The primary and secondary objective of this study is to determine whether PCSK9 inhibition
can improve arterial inflammation as assessed by FDG-PET/CT and endothelial function as
assessed by flow mediated vasodilation. The investigators will correlate changes in arterial
inflammation and endothelial function with lipids and markers of inflammation and immune
activation.
The tertiary objective is to perform a pilot evaluation of the impact of PCSK9 inhibition on
non-calcified plaque as measured by coronary CT angiography. Non-calcified plaque
measurements will be correlated with changes in lipid parameters and markers of inflammation
and immune activation.