Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

NCT03402815 | Completed Phase 4

• 1 other identifier: UPerugia03
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV; Maraviroc; Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Change Flow Mediated Dilation

  24 weeks

• Change in Intima-Media Thickness

  24 weeks

• Change in carotid-femoral Pulse Wave Velocity

  24 weeks

Secondary Outcomes (2)

• change in inflammatory markers

  24 weeks

• Endothelial microparticles/endothelial progenitor cells ratio

  24 weeks

Study Arms (2)

A

EXPERIMENTAL

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.

Drug: Maraviroc 300 mg

B

EXPERIMENTAL

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.

Drug: Maraviroc 300 mg

Interventions

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.

A; B

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• Patients over 70 years of age, with life expectancy \< 12 months, with known platelets functional defects or alcohol chronic abuse were excluded.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Elisabetta Schiaroli

Perugia, 06126, Italy

Location

MeSH Terms

Conditions

Atherosclerosis; Inflammation

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: January 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

IT (1)