Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

NCT03402815 — Phase 4, Completed, 22 participants, University Of Perugia

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Registry	NCT03402815
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: single, treatment
Enrollment	22 (Actual)
Sponsor	University Of Perugia (Other)
Conditions	HIV Infection With Other Conditions, Cardiovascular Risk Factor, Atherosclerosis, Inflammation
Interventions	Maraviroc 300 mg (Drug)
Dates	start 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 in Italy

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
A	Experimental	Drug: 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.
B	Experimental	Drug: 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.

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.

+Outcome measures

Primary outcomes

Change Flow Mediated Dilation [24 weeks]
Change in Intima-Media Thickness [24 weeks]
Change in carotid-femoral Pulse Wave Velocity [24 weeks]

Secondary outcomes

change in inflammatory markers [24 weeks]: change in CRP, IL6, D-dimer
Endothelial microparticles/endothelial progenitor cells ratio [24 weeks]

+Eligibility

Sex: All, ages: 50 Years to 70 Years

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)

Facility	City	Country	Status
Elisabetta Schiaroli	Perugia	Italy