The St. Marys and The Mater Switch Study

NCT00981773 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-09-12

No results posted yet for this study

Summary

The aim of the study is to determine whether switching from an antiretroviral regimen containing abacavir and/or didanosine to one containing maraviroc will lead to a reduction in platelet reactivity and inflammatory markers at weeks 12 and 24 thereby conferring a reduction in cardiac risk.

In addition the study will assess the efficacy of a maraviroc containing regimen in combination with a boosted protease inhibitor in terms of tolerability and achieving long term viral suppression as assessed at week 48.

The investigators hypothesize that there will be a rapid reduction in platelet reactivity on switching to maraviroc and that a boosted protease inhibitor in combination with maraviroc will provide a safe and efficacious antiretroviral regimen enabling a reduction in cardiac risk whilst maintaining virological suppression.

Conditions

  • HIV Infections

Interventions

DRUG

Maraviroc

Maraviroc 150 mg bid

DRUG

Maraviroc

maraviroc 150 mg bid switch 12 weeks later

Sponsors & Collaborators

  • Mater Misericordiae University Hospital

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • Alan Winston, MBChB · Imperial College London

  • Patrick Mallon, MBChB · UCD School of Medicine and Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00981773 on ClinicalTrials.gov