The St. Marys and The Mater Switch Study (SMASH)

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  21838

• Contact name

  Alan Winston

• Eudract number

  2009-011538-93

• ISRCTN Number

  ISRCTN

• Research summary

  People living with HIV infection may be at greater risk of developing heart disease. This may be due to a combination of factors including changes related to the HIV virus itself and side effects of some antiretroviral medications. Abacavir and didanosine, nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral drugs commonly used to treat HIV infection, have been shown to increase the risk of myocardial infarction (heart attack); however the reason for this is not clear and is independent of common antiretroviral side effects such as high cholesterol levels. Myocardial infarction (MI) may be triggered by inflammatory responses in the blood or changes in the blood??s clotting ability. A recent study showed that patients receiving abacavir had hyper-reactive platelets (a component of blood that helps clotting) compared to patients on other NRTIs. Another study showed raised levels of blood inflammatory markers in patients receiving abacavir. It is possible that abacavir and didanosine trigger MI by causing changes in platelet activity and blood inflammation. The aim of this study is therefore to assess changes in platelet reactivity, blood inflammatory markers and immunological and metabolic markers in HIV infected patients undergoing a switch from an abacavir and/or didanosine containing antiretroviral regimen to a regimen containing maraviroc. Maraviroc is a newly licensed drug that works by blocking entry of the HIV virus into the CD4 cells through a cell receptor called the CCR5 receptor. Patients with stable HIV infection who are currently receiving abacavir or didanosine in combination with a boosted protease inhibitor antiretroviral drug will be eligible for the study. The study will take place across 3 sites in London and Ireland and will involve 8 visits over a one year period. Platelet reactivity and inflammatory markers will be assessed over the course of the study alongside metabolic parameters and CD4 and viral load.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/47

• Date of REC Opinion

  1 Sep 2009

• REC opinion

  Further Information Favourable Opinion