NCT03402815

Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection With Other Conditions
• Cardiovascular Risk Factor
• Atherosclerosis
• Inflammation

Interventions

Type	Name	Description
DRUG	Maraviroc 300 mg	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-04-30
• Completion: 2017-09-30
• First posted: 2018-01-18
• Last updated: 2018-01-23

Locations

1 site across 1 country: Italy