Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
399 participants
INTERVENTIONAL
2011-08-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No change
continue their current cART regimen
No interventions assigned to this group
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
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.
Replace PI/r drugs with Maraviroc
Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Pfizer
INDUSTRY
Kirby Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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David A Cooper, AO
Role: PRINCIPAL_INVESTIGATOR
Kirby Institute, University of New South Wales
Locations
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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
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
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Gladstone Road Medical Centre
Bisbane, Queensland, Australia
Brisbane Sexual Health and HIV Service (formerly AMU)
Brisbane, Queensland, Australia
Nambour General Hospital
Nambour, Queensland, Australia
O'Brien Street Practice
Adelaide, South Australia, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Southern Alberta Clinic
Calgary, Alberta, Canada
University Health Network/Toronto General Hospital
Toronto, Ontario, Canada
Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
Toronto, Ontario, Canada
Clinic Opus/Lori
Montreal, Quebec, Canada
Fundación Arriarán
Santiago, Santiago RM, Chile
Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
Orléans, , France
Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
Frankfurt, Frankfurt Am Main, Germany
Gemeinschaftspraxis Jessen Jessen Stein
Berlin, State of Berlin, Germany
Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
Berlin, , Germany
University of Bonn, Med J. Immunologische Siudienzenirale
Bonn, , Germany
Klinikum der Universitat Zu Koln
Cologne, , Germany
Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
Düsseldorf, , Germany
Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
Hanover, , Germany
Mater Misericordiae University Hospital
Dublin, Dublin, Ireland
Nagoya Medical Center
Nagoya, , Japan
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico
Hospital General de Leon
León, , Mexico
INCMNSZ
Mexico City, , Mexico
Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
Warsaw, Warsaw, Poland
Hospital Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Regional Carlos Haya de Málaga
Málaga, Malaga, Spain
Hospital La Paz,
Madrid, , Spain
Hospital Principe de Asturias
Madrid, , Spain
Virgen Del Rocio University Hospital
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Chulalongkorn University Hospital
Bangkok, Bangkok, Thailand
St. Mary's Hospital, Imperial College
London, London, United Kingdom
St. Thomas's Hospital
London, London, United Kingdom
Western General Hospital
Edinburgh, Lothian, United Kingdom
Brighton & Sussex University NHS Trust
Brighton, Sussex, United Kingdom
Coventry and Warwickshire Partnership Trust
Coventry, Warwickshire, United Kingdom
Countries
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References
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Pett SL, Amin J, Horban A, Andrade-Villanueva J, Losso M, Porteiro N, Sierra Madero J, Belloso W, Tu E, Silk D, Kelleher A, Harrigan R, Clark A, Sugiura W, Wolff M, Gill J, Gatell J, Fisher M, Clarke A, Ruxrungtham K, Prazuck T, Kaiser R, Woolley I, Arnaiz JA, Cooper D, Rockstroh JK, Mallon P, Emery S; Maraviroc Switch (MARCH) Study Group. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study. Clin Infect Dis. 2016 Jul 1;63(1):122-32. doi: 10.1093/cid/ciw207. Epub 2016 Apr 5.
Tu E, Swenson LC, Land S, Pett S, Emery S, Marks K, Kelleher AD, Kaye S, Kaiser R, Schuelter E, Harrigan R; MARCH Laboratory Group and the MARCH Study Group. Results of external quality assessment for proviral DNA testing of HIV tropism in the Maraviroc Switch collaborative study. J Clin Microbiol. 2013 Jul;51(7):2063-71. doi: 10.1128/JCM.00510-13. Epub 2013 Apr 17.
Related Links
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Kirby Institute for infection and immunity in society homepage - click here for more information on the MARCH study.
Other Identifiers
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2011-01-MAR
Identifier Type: -
Identifier Source: org_study_id
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