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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
399

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Leon
      • 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 Príncipe de Asturias
      • Malaga, Spain, 29010
        • Hospital Regional Carlos Haya De Malaga
      • Seville, Spain, 41013
        • Virgen del Rocío 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirby Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
ViiV Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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