The St. Marys and The Mater Switch Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00981773
• Date of registration: 21/09/2009
• Primary sponsor: Imperial College London
• Public title: The St. Marys and The Mater Switch Study SMASH
• Scientific title: A Prospective, Randomised Study to Assess Safety, Changes in Platelet Reactivity, Plasma Cardiac Biomarkers, Immunological and Metabolic Parameters in HIV-1 Infected Subjects Undergoing a Switch in Antiretroviral Therapy
• Date of first enrolment: September 2009
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00981773
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Ireland, United Kingdom

Contacts

• Name: Alan Winston, MBChB

• Name: Alan Winston, MBChB
• Affiliation: Imperial College London

• Name: Patrick Mallon, MBChB
• Affiliation: UCD School of Medicine and Medical Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Maraviroc

Primary Outcome(s)

Mean change from baseline in platelet reactivity between treatment arms at week 12 [Time Frame: 48 weeks]

Secondary Outcome(s)

To assess for the following: Mean change over 24 weeks and mean difference at week 12 between study groups in plasma inflammatory and cardiac biomarkers and markers of immune activation [Time Frame: 48 weeks]

Secondary ID(s)

1.0 18.6.2009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mater Misericordiae University Hospital