HIV Infection Clinical Trial
Official title:
Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy
The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy
(HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new
complications have appeared in HIV-infected patients treated by with HAART such as
dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular
complications including acute coronary syndromes, peripheral vascular disease, and stroke
have been reported.
A linear association has been proved between increased intima-media thickness of the common
carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of
cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of
atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular
events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT
in HIV-infected patients under HAART compared with non-HIV infected patients with different
progression.
The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic
stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution
echotracking system.
Patients in the pravastatin group were consecutively recruited in four department of
infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with
HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160
mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one
more coronary risk factor. The patients in the control group were selected consecutively in
the same departments among 1) HIV-infected patients treated with HAART > 12 months 2)
fasting serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more
coronary risk factor. Cases and control patients were matched for age, gender and tobacco
consumption.
Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups
was the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a
two-sided test (a = 0.05, b = 0.20).
The protocol of the study, sponsored by the French Society of Cardiology was approved by the
Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière
University hospital in Paris. Written informed consent to participate in the study was
obtained from each patient.
n/a
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