The St. Marys and The Mater Switch Study (SMASH)
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ClinicalTrials.gov Identifier: NCT00981773 |
Recruitment Status
:
Completed
First Posted
: September 22, 2009
Last Update Posted
: May 21, 2014
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Maraviroc | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981773
Ireland | |
Cork University Hospital | |
Cork, Ireland | |
Mater Misericordiae University Hospital | |
Dublin, Ireland | |
United Kingdom | |
Imperial College Healthcare NHS Trust | |
London, United Kingdom, W2 1NY |
Principal Investigator: | Alan Winston, MBChB | Imperial College London | |
Principal Investigator: | Patrick Mallon, MBChB | UCD School of Medicine and Medical Sciences |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00981773 History of Changes |
Other Study ID Numbers: |
1.0 18.6.2009 |
First Posted: | September 22, 2009 Key Record Dates |
Last Update Posted: | May 21, 2014 |
Last Verified: | May 2011 |
Keywords provided by Imperial College London:
HIV switch HIV treatment experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |