Status:
TERMINATED
The St. Marys and The Mater Switch Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Mater Misericordiae University Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
To assess the safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters in HIV 1 infected subjects undergoing a switch in ART from a nucleoside containing regimen whic...
Eligibility Criteria
Inclusion
- HIV-1 infected males or females
- Between 18 and 65 years of age
- Signed informed consent
- Currently receiving a stable antiretroviral regimen comprising of:
- two licensed NRTIs including abacavir and/or didanosine
- any licensed boosted protease inhibitor at any dose (excluding tipranavir\*)
- Undetectable plasma HIV RNA to less than 50 copies/mL for at least 24 weeks prior to screening
- Availability of stored plasma with which to perform a tropism assay
- CCR5 tropic HIV virus based on a tropism assay from a stored plasma sample
- Willing to continue unchanged, or to modify antiretroviral therapy, in accordance with the randomisation assignment
- No documented viral resistance to currently licensed HIV-1 protease inhibitors based either on previous HIV-1 genotypic resistance testing or in the judgement of the study investigators
- No previous exposure to maraviroc or CCR5 receptor antagonists
- Subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator
- Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must avoid becoming pregnancy as follows from screening through completion of the study using one or both of the following methods:
- barrier contraceptives (condom, diaphragm with spermicide)
- IUD PLUS a barrier contraceptive
- Female subjects of childbearing potential must have a negative pregnancy test
Exclusion
- failure of current antiretroviral regimen due to virological failure
- active opportunistic infection, malignancy or significant co-morbidities in the opinion of the investigator
- pregnancy
- current prohibited concomitant medication (as listed in section 4.1.4)
- no available stored plasma sample predating their current antiretroviral regimen upon which a tropism assay can be performed
- active HBV infection as evidenced by positive hepatitis B surface antigen
- active hepatitis C virus infection as evidenced by positive HCV PCR or HCV antibody.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00981773
Start Date
September 1 2009
End Date
March 1 2013
Last Update
September 12 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Cork University Hospital
Cork, Ireland
2
Mater Misericordiae University Hospital
Dublin, Ireland
3
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY