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Completed

NCT Number: NCT03402815

Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

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.

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Key information

Conditions

HIV Infection With Other Conditions Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Cardiovascular Risk Factor Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Elisabetta Schiaroli

Perugia, 06126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maraviroc 300 mg

Drug

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.

Primary outcomes

  1. Change Flow Mediated Dilation

    Time frame: 24 weeks

  2. Change in Intima-Media Thickness

    Time frame: 24 weeks

  3. Change in carotid-femoral Pulse Wave Velocity

    Time frame: 24 weeks

Secondary outcomes

  1. change in inflammatory markers

    Time frame: 24 weeks

    change in CRP, IL6, D-dimer

  2. Endothelial microparticles/endothelial progenitor cells ratio

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2018
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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