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Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402815
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Elisabetta Schiaroli, University Of Perugia

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.

Condition or disease Intervention/treatment Phase
HIV Infection With Other Conditions Cardiovascular Risk Factor Atherosclerosis Inflammation Drug: Maraviroc 300 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Maraviroc

Arm Intervention/treatment
Experimental: A
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
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.

Experimental: B
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
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402815


Locations
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Italy
Elisabetta Schiaroli
Perugia, Italy, 06126
Sponsors and Collaborators
University Of Perugia

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Responsible Party: Elisabetta Schiaroli, Researcher, University Of Perugia
ClinicalTrials.gov Identifier: NCT03402815    
Other Study ID Numbers: UPerugia03
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elisabetta Schiaroli, University Of Perugia:
HIV
Maraviroc
Atherosclerosis
Additional relevant MeSH terms:
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Atherosclerosis
Inflammation
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Maraviroc
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists