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Maraviroc Switch Collaborative Study (MARCH)

18. januar 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

399

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2010
        • St. Vincent's Hospital
    • Queensland
      • Bisbane, Queensland, Australia, 4101
        • Gladstone Road Medical Centre
      • Brisbane, Queensland, Australia, 4000
        • Brisbane Sexual Health and HIV Service (formerly AMU)
      • Nambour, Queensland, Australia, 4560
        • Nambour General Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • O'Brien Street Practice
    • Victoria
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 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
  • Frankrike
      • Orleans, Frankrike, 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
  • Spania
      • Madrid, Spania, 28046
        • Hospital La Paz,
      • Madrid, Spania, 28805
        • Hospital Príncipe de Asturias
      • Malaga, Spania, 29010
        • Hospital Regional Carlos Haya De Malaga
      • Seville, Spania, 41013
        • Virgen del Rocio University Hospital
      • Valencia, Spania, 46026
        • Hospital Universitari i Politecnic La Fe
    • Catalonia
      • Badalona, Catalonia, Spania, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Catalonia, Spania, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Catalonia, Spania, 08041
        • Hospital de la Santa Creu i Sant Pau
  • Storbritannia
      • London, Storbritannia, W2
        • St. Mary's Hospital, Imperial College
      • London, Storbritannia
        • St. Thomas's Hospital
    • Lothian
      • Edinburgh, Lothian, Storbritannia
        • Western General Hospital
    • Sussex
      • Brighton, Sussex, Storbritannia, BN21ES
        • Brighton & Sussex University NHS Trust
    • Warwickshire
      • Coventry, Warwickshire, Storbritannia, CV 1 4FS
        • Coventry and Warwickshire Partnership Trust
  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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
Legemiddel: 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.
Legemiddel: 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.

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kirby Institute

Samarbeidspartnere

Pfizer
ViiV Healthcare

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2011

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. desember 2015

Datoer for studieregistrering

Først innsendt

28. juni 2011

Først innsendt som oppfylte QC-kriteriene

28. juni 2011

Først lagt ut (Anslag)

29. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. januar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. januar 2016

Sist bekreftet

1. januar 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2011-01-MAR

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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