Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

Phase 4

Completed

• Conditions: Cardiovascular Risk Factor; HIV Infection With Other Conditions; Atherosclerosis; Inflammation
• Interventions: Drug: Maraviroc 300 mg

• Registration Number: NCT03402815
• Lead Sponsor: University Of Perugia

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-09-30
• Status Verified: 2018-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Maraviroc 300 mg	Patients received ART with no additional treatment for 24 weeks. At the end of the first 24-week period patients were switched to Maraviroc 300 mg/day in addition to current ART.
A	Maraviroc 300 mg	Patients received Maraviroc 300 mg/day in addition to current ART for 24 weeks. At the end of the first 24-week period patients were switched to ART with no additional treatment.

Primary Outcome Measures

Name	Time	Method
Change Flow Mediated Dilation	24 weeks
Change in Intima-Media Thickness	24 weeks
Change in carotid-femoral Pulse Wave Velocity	24 weeks

Secondary Outcome Measures

Name	Time	Method
Endothelial microparticles/endothelial progenitor cells ratio	24 weeks
change in inflammatory markers	24 weeks	change in CRP, IL6, D-dimer

Trial Locations

Locations (1)

Elisabetta Schiaroli; 🇮🇹 Perugia, Italy