The St. Marys and The Mater Switch Study
NCT00981773 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2019-09-12
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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