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Maraviroc Switch Collaborative Study (MARCH)

18. januar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

399

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
    • New South Wales
      • Sydney, New South Wales, Australien, 2010
        • Holdsworth House Medical Practice
      • Sydney, New South Wales, Australien, 2145
        • Westmead Hospital
      • Sydney, New South Wales, Australien, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australien, 2010
        • St. Vincent's Hospital
    • Queensland
      • Bisbane, Queensland, Australien, 4101
        • Gladstone Road Medical Centre
      • Brisbane, Queensland, Australien, 4000
        • Brisbane Sexual Health and HIV Service (formerly AMU)
      • Nambour, Queensland, Australien, 4560
        • Nambour General Hospital
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • O'Brien Street Practice
    • Victoria
      • Melbourne, Victoria, Australien, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australien, 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
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, W2
        • St. Mary's Hospital, Imperial College
      • London, Det Forenede Kongerige
        • St. Thomas's Hospital
    • Lothian
      • Edinburgh, Lothian, Det Forenede Kongerige
        • Western General Hospital
    • Sussex
      • Brighton, Sussex, Det Forenede Kongerige, BN21ES
        • Brighton & Sussex University NHS Trust
    • Warwickshire
      • Coventry, Warwickshire, Det Forenede Kongerige, CV 1 4FS
        • Coventry and Warwickshire Partnership Trust
  • Frankrig
      • Orleans, Frankrig, 45100
        • Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
  • Irland
      • Dublin, Irland, 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
  • Polen
      • Warsaw, Polen, 01-201
        • Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
  • Spanien
      • Madrid, Spanien, 28046
        • Hospital La Paz,
      • Madrid, Spanien, 28805
        • Hospital Príncipe de Asturias
      • Malaga, Spanien, 29010
        • Hospital Regional Carlos Haya De Malaga
      • Seville, Spanien, 41013
        • Virgen del Rocio University Hospital
      • Valencia, Spanien, 46026
        • Hospital Universitari i Politecnic La Fe
    • Catalonia
      • Badalona, Catalonia, Spanien, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Catalonia, Spanien, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Catalonia, Spanien, 08041
        • Hospital De La Santa Creu I Sant Pau
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University Hospital
  • Tyskland
      • Berlin, Tyskland, 10777
        • Gemeinschaftspraxis Jessen Jessen Stein
      • Berlin, Tyskland, 13353
        • Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
      • Bonn, Tyskland, 53127
        • University of Bonn, Med J. Immunologische Siudienzenirale
      • Cologne, Tyskland, 50937
        • Klinikum der Universität zu Köln
      • Düsseldorf, Tyskland, 40225
        • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
      • Hannover, Tyskland, 30625
        • Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
    • Frankfurt am Main
      • Frankfurt, Frankfurt am Main, Tyskland, 60590
        • Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: No change
continue their current cART regimen
Aktiv komparator: 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
Medicin: 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.
Aktiv komparator: Replace PI/r drugs with Maraviroc
Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
Tidsramme: 48 weeks after randomization
48 weeks after randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kirby Institute

Samarbejdspartnere

Pfizer
ViiV Healthcare

Efterforskere

  • Ledende efterforsker: David A Cooper, AO, Kirby Institute, University of New South Wales

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

28. juni 2011

Først indsendt, der opfyldte QC-kriterier

28. juni 2011

Først opslået (Skøn)

29. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-01-MAR

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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