MARCH study

• Research type

  Research Study

• Full title

  A randomised, open label study to evaluate the efficacy and safety of maraviroc(MVC) as a switch for N(t)RTI or PI/r in HIV1 infected individuals with stable, well controlled plasma HIV RNA while taking their first N(t)RTI + PI/r regimen of cART.

• IRAS ID

  85431

• Contact name

  Martin Fisher

• Sponsor organisation

  University of New South Wales

• Eudract number

  2011-002107-15

• Clinicaltrials.gov Identifier

  NCT01384682

• Research summary

  Treatment guidelines for HIV currently recommend the use of combination antiretroviral therapy. There are several different types of antiretroviral medication and the commonly used ones are reverse transcriptase inhibitors (RTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI/r). Different combinations of these medications are recommended for reducing the amount of HIV in the body. People taking antiretroviral therapy can still experience side effects. From previous research it seems that some of these side are associated with both PIs and N(t)RTI. CD4 Tcells are important immune cells; one of the receptors (proteins) on the surface of these cells is called chemokinereceptor (CCR5). Not all people have this receptor on their cells. HIV often uses the CCR5 receptor to get into the cell. Maraviroc is an antiviral drug that works by blocking the CCR5 receptor so that HIV cannot bind to it. The main aim of this study is to investigate whether switching maraviroc, in combination with either RTI or PI/r, is as good at keeping the amount of HIV in patients?? blood undetectable (below the level of the standard tests in the laboratory) as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc result in an improvement in some of the side effects that can be seen when people take combination therapy including RTI and PI/r.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  11/LO/1588

• Date of REC Opinion

  18 Nov 2011

• REC opinion

  Further Information Favourable Opinion