Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

Inflammation Clinical Trial

Official title:

Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402815
• Other study ID #: UPerugia03
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2018
• Last updated: January 19, 2018
• Start date: January 1, 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2018
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Elisabetta Schiaroli	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Flow Mediated Dilation		24 weeks
Primary	Change in Intima-Media Thickness		24 weeks
Primary	Change in carotid-femoral Pulse Wave Velocity		24 weeks
Secondary	change in inflammatory markers	change in CRP, IL6, D-dimer	24 weeks
Secondary	Endothelial microparticles/endothelial progenitor cells ratio		24 weeks