MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients
who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will
be randomized (1:2:2) to one of three treatment groups: to continue their current treatment
regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily
with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic
assessment of tropism cannot be used to determine tropism, instead we will employ the
genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim
of this study is to investigate whether switching to maraviroc, in combination with either
RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI
with PI/r. The other aim is to see if switching to these combinations with maraviroc will
improve some of the side effects that can be seen when people take combination therapy
including RTI and PI/r.
The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200
copies/mL) patients with no history of prior virological failure, a switch to either MVC
dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC
dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the
investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral
efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.