Maraviroc Switch Collaborative Study

clinicaltrials.gov

Summary
MARCH is an international, multicentre trial planning to enroll HIV-1 infected patients who are currently  virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups

  1. to continue their current treatment regimen
  2. maraviroc dose at 150 mg twice daily with PI/r, or
  3. maraviroc at 300 mg twice daily with 2N(t)RTI.

Aims
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
  • 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=”” the=”” same=”” 2n=”” t=”” rti=”” backbone=”” regimen=”” or=”” 150mg=”” current=”” pi=”” r=”” discretion=”” investigator=”” if=”” is=”” fosamprenavir=”” provides=”” similar=”” non-inferior=”” antiretroviral=”” efficacy=”” compared=”” continuation=”” br=””>
Primary Outcome Measures
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies=”” ml=”” 48=”” weeks=”” after=”” randomisation=”” br=””>
Secondary Outcome Measures

  • Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies=”” ml=”” time=”” frame:=”” 48=”” weeks=”” from=”” randomization=”” li=””>
  • Immunologic and biomarkers
  • Clinical
  • Metabolic and body composition
  • Safety
  • Adherence
  • Quality of Life
  • Resistance endpoints
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