The St. Marys and The Mater Switch Study (SMASH)
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Maraviroc |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official 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 |
- Mean change from baseline in platelet reactivity between treatment arms at week 12 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 40 |
Study Start Date: | September 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Immediate switch
|
Drug: Maraviroc
Maraviroc 150 mg bid
|
Active Comparator: Continue current antiretroviral therapy
|
Drug: Maraviroc
maraviroc 150 mg bid switch 12 weeks later
|
Show Detailed Description
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Contact: Alan Winston, MBChB | +44 20 7886 1603 | a.winston@imperial.ac.uk |
Contact: Kenneth R Legg, BSc | 44 20 7886 1464 | k.legg@imperial.ac.uk |
Ireland | |
Cork University Hospital | Not yet recruiting |
Cork, Ireland | |
Contact: Mary Horgan Mary.Horgan2@mailp.hse.ie | |
Principal Investigator: Mary Horgan | |
Mater Misericordiae University Hospital | Recruiting |
Dublin, Ireland | |
Contact: Claudette Satchell | |
Principal Investigator: Patrick Mallon | |
United Kingdom | |
Imperial College Healthcare NHS Trust | Recruiting |
London, United Kingdom, W2 1NY | |
Contact: Kristin Kuldanek, MSc 020 3312 6047 k.kuldanek@imperial.ac.uk | |
Contact: Ken Legg, BSc 020 3312 1464 k.legg@imperial.ac.uk | |
Principal Investigator: Alan Winston |
Principal Investigator: | Alan Winston, MBChB | Imperial College London |
Principal Investigator: | Patrick Mallon, MBChB | UCD School of Medicine and Medical Sciences |
No publications provided
Responsible Party: | Dr Alan Winston, Imperial College London |
ClinicalTrials.gov Identifier: | NCT00981773 History of Changes |
Other Study ID Numbers: | 1.0 18.6.2009 |
Study First Received: | September 21, 2009 |
Last Updated: | May 25, 2011 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Imperial College London:
HIV switch HIV treatment experienced |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2013