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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
399
Maraviroc is a marketed drug for the treatment of HIV-infection. Maraviroc will be supplied in two different oral dose forms, 150mg and 300mg given twice a day. The drug will be dosed according to the recommendations in the product label i.e. with PI/r the dose is 150mg bid except, Maraviroc 300mg bid can be used at the discretion of the investigator if the PI/r is fosamprenavir/r; those randomised to the 2N(t)RTI arm, will receive Maraviroc 300mg bid. Patients randomised to receive Maraviroc will be provided with bottles of Maraviroc which contain a 30-day supply.
Fundacion IDEAA
Buenos Aires, Buenos Aires, Argentina
Hospital Nacional Prof Alejandro Posadas
El Palomar, Buenos Aires, Argentina
Hospital Dr Diego Paroissien
Isidro Casanova, Buenos Aires, Argentina
FUNCEI
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
Time frame: 48 weeks after randomization
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
A number of secondary endpoints will be examined at or through to week 48 in this protocol. These will include, but not be limited to the following: Virologic; Immunologic and biomarkers; Clinical; Metabolic and body composition; Safety; Adherence; Quality of Life and Resistance endpoints.
Time frame: 48 weeks from randomization
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Hospital G de Agudos JM Ramos Mejia
Buenos Aires, Buenos Aires F.D., Argentina
CAICI
Rosario, Santa Fe Province, Argentina
Hospital Privado- Centro Medico Cordoba
Córdoba, Argentina
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
St. Vincent's Hospital
Sydney, New South Wales, Australia
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