Maraviroc Switch Collaborative Study

NCT01384682

Last updated date
Study Location
FUNCEI
Buenos Aires, Ciudad de Buenos Aires, 1425, Argentina
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Maraviroc Switch Collaborative Study
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Maraviroc
  • 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.
    Intervention: Drug: Maraviroc
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2016)
399
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2011)
560
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Chile,   France,   Germany,   Ireland,   Japan,   Mexico,   Poland,   Spain,   Thailand,   United Kingdom
Removed Location Countries Peru
 
Administrative Information
NCT Number  ICMJE NCT01384682
Other Study ID Numbers  ICMJE 2011-01-MAR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirby Institute
Study Sponsor  ICMJE Kirby Institute
Collaborators  ICMJE
  • ViiV Healthcare
  • Pfizer
Investigators  ICMJE
Principal Investigator:David A Cooper, AOKirby Institute, University of New South Wales
PRS Account Kirby Institute
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP