EUCTR2009-011538-93-GB
Active, not recruiting
Phase 1
A prospective, randomised study to assess safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters over 48 weeks in HIV-1 infected subjects undergoing a switch in antiretroviral therapy. - The St. Marys and The Mater Switch Study (SMASH)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Imperial College London
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 and 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
- •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
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
- •current prohibited concomitant medication
Outcomes
Primary Outcomes
Not specified
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