Maraviroc Switch Collaborative Study (MARCH)

January 18, 2016 updated by: Kirby Institute

Randomised, Openlabel Study Evaluating Efficacy and Safety of Maraviroc as a Switch for Either NRTI or PI/r in HIV-1 Infected Individuals With Stable, Well-Controlled Plasma HIV-RNA While Taking Their First N(t)RTI + PI/r Regimen of cART

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

399

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405CKC
        • Fundacion IDEAA
      • Cordoba, Argentina
        • Hospital Privado- Centro Medico Cordoba
    • Ciudad de Buenos Aires
      • Buenos Aires, Ciudad de Buenos Aires, Argentina, 1425
        • FUNCEI
      • Buenos Aires, Ciudad de Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Ciudad de Buenos Aires, Argentina, C1221ADC
        • Hospital G de Agudos JM Ramos Mejia
    • Provincia de Buenos Aires
      • El Palomar, Provincia de Buenos Aires, Argentina, 1684
        • Hospital Nacional Prof Alejandro Posadas
      • Isidro Casanova, Provincia de Buenos Aires, Argentina, 1765
        • Hospital Dr Diego Paroissien
    • Provincia de Santa Fe
      • Rosario, Provincia de Santa Fe, Argentina, S2000PBJ
        • CAICI
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2010
        • St. Vincent's Hospital
    • Queensland
      • Bisbane, Queensland, Australia, 4101
        • Gladstone Road Medical Centre
      • Brisbane, Queensland, Australia, 4000
        • Brisbane Sexual Health and HIV Service (formerly AMU)
      • Nambour, Queensland, Australia, 4560
        • Nambour General Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • O'Brien Street Practice
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R OX7
        • Southern Alberta Clinic
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network/Toronto General Hospital
      • Toronto, Ontario, Canada, ON M5G 1k2
        • Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
    • Quebec
      • Montreal, Quebec, Canada, H3A 1T1
        • Clinic Opus/Lori
  • Chile
    • Santiago RM
      • Santiago, Santiago RM, Chile
        • Fundacion Arriaran
  • France
      • Orleans, France, 45100
        • Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
  • Germany
      • Berlin, Germany, 10777
        • Gemeinschaftspraxis Jessen Jessen Stein
      • Berlin, Germany, 13353
        • Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
      • Bonn, Germany, 53127
        • University of Bonn, Med J. Immunologische Siudienzenirale
      • Cologne, Germany, 50937
        • Klinikum der Universität zu Köln
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
      • Hannover, Germany, 30625
        • Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
    • Frankfurt am Main
      • Frankfurt, Frankfurt am Main, Germany, 60590
        • Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
  • Ireland
      • Dublin, Ireland, 7
        • Mater Misericordiae University Hospital
  • Japan
      • Nagoya, Japan, 460-0001
        • Nagoya Medical Center
  • Mexico
      • Leon, Mexico, 37320
        • Hospital General de León
      • Mexico City, Mexico
        • INCMNSZ
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara
  • Poland
      • Warsaw, Poland, 01-201
        • Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
  • Spain
      • Madrid, Spain, 28046
        • Hospital La Paz,
      • Madrid, Spain, 28805
        • Hospital Principe de Asturias
      • Malaga, Spain, 29010
        • Hospital Regional Carlos Haya De Malaga
      • Seville, Spain, 41013
        • Virgen del Rocio University Hospital
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Catalonia
      • Badalona, Catalonia, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Catalonia, Spain, 08041
        • Hospital de la Santa Creu I Sant Pau
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University Hospital
  • United Kingdom
      • London, United Kingdom, W2
        • St. Mary's Hospital, Imperial College
      • London, United Kingdom
        • St. Thomas's Hospital
    • Lothian
      • Edinburgh, Lothian, United Kingdom
        • Western General Hospital
    • Sussex
      • Brighton, Sussex, United Kingdom, BN21ES
        • Brighton & Sussex University NHS Trust
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV 1 4FS
        • Coventry and Warwickshire Partnership Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented HIV-1 infection by a licensed diagnostic test at any time prior to study entry
  • Age >18 years
  • HIV-1 RNA <200 copies/mL plasma for at least 24 weeks
  • Stable (>24 weeks) ART including two N(t)RTIs and a PI/r
  • No evidence of any primary HIV genotypic mutations in HIV reverse transcriptase or protease for all patients with available resistance testing results conducted prior to cART and/or during viral rebound/failure
  • Provision of written, informed consent.

Exclusion Criteria:

  • CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a non-reportable tropism result based on assessment using proviral DNA
  • Anticipated need to modify current cART regimen for toxicity management in the next 6 months

  • The following laboratory criteria,

    1. absolute neutrophil count (ANC) <750 cells/µL
    2. haemoglobin <8.0 g/dL
    3. platelet count <50,000 cells/µL
    4. serum AST, ALT >5 x upper limit of normal (ULN)
  • Active hepatitis B co-infection
  • Pregnant women or nursing mothers
  • Current use of any prohibited medications as described in product specific information.
  • Hypersensitivity to soy or peanuts
  • Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation
  • Use of immunomodulators (e.g. systemic corticosteroids, recombinant interleukin-2, interferon) within 30 days prior to screening
  • Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the study
  • Patients unlikely to be able to remain in follow-up for the protocol-defined period
  • Prisoners or subjects who are compulsorily detained (involuntary incarcerated).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No change
continue their current cART regimen
Active Comparator: Replace N(t)RTI drugs with Maraviroc
Replace N(t)RTI drugs with MVC at a dose of 150mg bid (MVC 300mg bid can be used at the discretion of the Investigator if the PI/r is fosamprenavir/r) and continue the PI/r
Drug: Maraviroc
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.
Active Comparator: Replace PI/r drugs with Maraviroc
Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI.
Drug: Maraviroc
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
Time Frame: 48 weeks from randomization

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.
48 weeks from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

Pfizer
ViiV Healthcare

Investigators

  • Principal Investigator: David A Cooper, AO, Kirby Institute, University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 18, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-01-MAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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