Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

University Of Perugia22 enrolled

Overview

The investigator tested the efficacy of maraviroc intensification on down-regulating atherosclerotic progression in HIV infected patients with optimal viro-immunologic control and at high cardiovascular risk.

Experimental CCR5 antagonism with maraviroc in atherosclerosis-prone mice and preliminary data in humans suggest an anti-atherosclerotic effect of the drug. The investigators assessed the impact of maraviroc treatment in HIV-infected patients on several subclinical indicators of atherosclerosis and putative mechanisms for such an effect. HIV-treated patients under effective antiretroviral (ART) therapy, with a Framingham risk score \>20% and a brachial flow-mediated dilation (bFMD) \<4%, as indices of high cardiovascular risk, were recruited. Maraviroc (300 mg per os for 24 weeks) was administered on top of ART to all participants using a cross-over design. Brachial FMD, carotid-femoral pulse wave velocity (cfPWV) and carotid intima-media thickness (cIMT) were measured as non-invasive markers of atherosclerosis. Vascular competence, as expressed by the ratio of circulating endothelial micro-particles (EMPs) to endothelial progenitor cells (EPCs), as well as markers of systemic inflammation, monocyte activation and platelet activation were assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

HIV Infection With Other Conditions Cardiovascular Risk Factor Atherosclerosis Inflammation

Interventions

Maraviroc 300 mgDRUG

Patients were randomly allocated with an AB/BA cross over design to either maraviroc 300 mg/day to current ART for 24 weeks (A) or no additional treatment (B). At the end of the first 24-week period patients were switched to the alternative arm.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eligible patients were consecutive ≥50-year-old individuals, treated for over 1 year with an effective protease inhibitor ART regimen (HIV RNA \<50 copies/mL), with CD4 T cell counts \> 300/ mm3 for at least 6 months and a Framingham risk score \>20% and bFMD \<4%. Exclusion Criteria: * Patients over 70 years of age, with life expectancy \< 12 months, with known platelets functional defects or alcohol chronic abuse were excluded.

Locations (1)

Elisabetta Schiaroli

Perugia, Italy

Outcomes

Primary Outcomes

Change Flow Mediated Dilation

Time frame: 24 weeks

Change in Intima-Media Thickness

Time frame: 24 weeks

Change in carotid-femoral Pulse Wave Velocity

Time frame: 24 weeks

Secondary Outcomes

change in inflammatory markers

change in CRP, IL6, D-dimer

Time frame: 24 weeks

Endothelial microparticles/endothelial progenitor cells ratio

Time frame: 24 weeks

Data from ClinicalTrials.gov

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