- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01384682
Maraviroc Switch Collaborative Study (MARCH)
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.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 10777
- Gemeinschaftspraxis Jessen Jessen Stein
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Berlin, Alemanha, 13353
- Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
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Bonn, Alemanha, 53127
- University of Bonn, Med J. Immunologische Siudienzenirale
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Cologne, Alemanha, 50937
- Klinikum der Universität zu Köln
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Düsseldorf, Alemanha, 40225
- Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
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Hannover, Alemanha, 30625
- Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
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Frankfurt am Main
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Frankfurt, Frankfurt am Main, Alemanha, 60590
- Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
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Buenos Aires, Argentina, C1405CKC
- Fundacion IDEAA
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Cordoba, Argentina
- Hospital Privado- Centro Medico Cordoba
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Ciudad de Buenos Aires
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Buenos Aires, Ciudad de Buenos Aires, Argentina, 1425
- FUNCEI
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Buenos Aires, Ciudad de Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, Ciudad de Buenos Aires, Argentina, C1221ADC
- Hospital G de Agudos JM Ramos Mejia
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Provincia de Buenos Aires
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El Palomar, Provincia de Buenos Aires, Argentina, 1684
- Hospital Nacional Prof Alejandro Posadas
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Isidro Casanova, Provincia de Buenos Aires, Argentina, 1765
- Hospital Dr Diego Paroissien
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Provincia de Santa Fe
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Rosario, Provincia de Santa Fe, Argentina, S2000PBJ
- CAICI
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New South Wales
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Sydney, New South Wales, Austrália, 2010
- Holdsworth House Medical Practice
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Sydney, New South Wales, Austrália, 2145
- Westmead Hospital
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Sydney, New South Wales, Austrália, 2050
- Royal Prince Alfred Hospital
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Sydney, New South Wales, Austrália, 2010
- St. Vincent's Hospital
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Queensland
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Bisbane, Queensland, Austrália, 4101
- Gladstone Road Medical Centre
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Brisbane, Queensland, Austrália, 4000
- Brisbane Sexual Health and HIV Service (formerly AMU)
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Nambour, Queensland, Austrália, 4560
- Nambour General Hospital
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South Australia
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Adelaide, South Australia, Austrália, 5000
- O'Brien Street Practice
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Victoria
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Melbourne, Victoria, Austrália, 3168
- Monash Medical Centre
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Melbourne, Victoria, Austrália, 3004
- Alfred Hospital
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Alberta
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Calgary, Alberta, Canadá, T2R OX7
- Southern Alberta Clinic
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Ontario
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Toronto, Ontario, Canadá, M5G 2N2
- University Health Network/Toronto General Hospital
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Toronto, Ontario, Canadá, ON M5G 1k2
- Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
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Quebec
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Montreal, Quebec, Canadá, H3A 1T1
- Clinic Opus/Lori
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Santiago RM
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Santiago, Santiago RM, Chile
- Fundacion Arriaran
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Madrid, Espanha, 28046
- Hospital La Paz,
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Madrid, Espanha, 28805
- Hospital Principe de Asturias
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Malaga, Espanha, 29010
- Hospital Regional Carlos Haya De Malaga
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Seville, Espanha, 41013
- Virgen del Rocío University Hospital
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Valencia, Espanha, 46026
- Hospital Universitari I Politecnic La Fe
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Catalonia
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Badalona, Catalonia, Espanha, 08916
- Hospital Germans Trias i Pujol
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Barcelona, Catalonia, Espanha, 08036
- Hospital Clínic de Barcelona
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Barcelona, Catalonia, Espanha, 08041
- Hospital de la Santa Creu i Sant Pau
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Orleans, França, 45100
- Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
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Dublin, Irlanda, 7
- Mater Misericordiae University Hospital
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Nagoya, Japão, 460-0001
- Nagoya Medical Center
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Leon, México, 37320
- Hospital General de León
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Mexico City, México
- INCMNSZ
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Jalisco
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Guadalajara, Jalisco, México, 44280
- Hospital Civil de Guadalajara
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Warsaw, Polônia, 01-201
- Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
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London, Reino Unido, W2
- St. Mary's Hospital, Imperial College
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London, Reino Unido
- St. Thomas's Hospital
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Lothian
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Edinburgh, Lothian, Reino Unido
- Western General Hospital
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Sussex
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Brighton, Sussex, Reino Unido, BN21ES
- Brighton & Sussex University NHS Trust
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Warwickshire
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Coventry, Warwickshire, Reino Unido, CV 1 4FS
- Coventry and Warwickshire Partnership Trust
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Bangkok, Tailândia, 10330
- Chulalongkorn University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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,
- absolute neutrophil count (ANC) <750 cells/µL
- haemoglobin <8.0 g/dL
- platelet count <50,000 cells/µL
- 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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: No change
continue their current cART regimen
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Comparador Ativo: 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
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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.
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Comparador Ativo: Replace PI/r drugs with Maraviroc
Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
Prazo: 48 weeks after randomization
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48 weeks after randomization
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
Prazo: 48 weeks from randomization
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David A Cooper, AO, Kirby Institute, University of New South Wales
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2011-01-MAR
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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