Maraviroc Switch Collaborative Study (MARCH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ViiV Healthcare
Pfizer
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01384682
First received: June 28, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
HIV
Drug: Maraviroc
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

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. [ Time Frame: 48 weeks after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml [ Time Frame: 48 weeks from randomization ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 380
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384682

  Show 51 Study Locations
Sponsors and Collaborators
Kirby Institute
ViiV Healthcare
Pfizer
Investigators
Principal Investigator: David A Cooper, AO Kirby Institute, University of New South Wales
  More Information

Additional Information:
No publications provided by Kirby Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01384682     History of Changes
Other Study ID Numbers: 2011-01-MAR
Study First Received: June 28, 2011
Last Updated: July 16, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Chile: Ministry of Health
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Ministry of Health
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Ministry of Health

ClinicalTrials.gov processed this record on August 20, 2014