Maraviroc Switch Collaborative Study (MARCH)
18 januari 2016 uppdaterad 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
399
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Australien, 2010
- Holdsworth House Medical Practice
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Sydney, New South Wales, Australien, 2145
- Westmead Hospital
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Sydney, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital
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Sydney, New South Wales, Australien, 2010
- St. Vincent's Hospital
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Queensland
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Bisbane, Queensland, Australien, 4101
- Gladstone Road Medical Centre
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Brisbane, Queensland, Australien, 4000
- Brisbane Sexual Health and HIV Service (formerly AMU)
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Nambour, Queensland, Australien, 4560
- Nambour General Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- O'Brien Street Practice
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Victoria
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Melbourne, Victoria, Australien, 3168
- Monash Medical Centre
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Melbourne, Victoria, Australien, 3004
- Alfred Hospital
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Santiago RM
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Santiago, Santiago RM, Chile
- Fundacion Arriaran
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Orleans, Frankrike, 45100
- Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
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Dublin, Irland, 7
- Mater Misericordiae University Hospital
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Nagoya, Japan, 460-0001
- Nagoya Medical Center
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Alberta
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Calgary, Alberta, Kanada, T2R OX7
- Southern Alberta Clinic
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Ontario
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Toronto, Ontario, Kanada, M5G 2N2
- University Health Network/Toronto General Hospital
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Toronto, Ontario, Kanada, ON M5G 1k2
- Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
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Quebec
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Montreal, Quebec, Kanada, H3A 1T1
- Clinic Opus/Lori
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Leon, Mexiko, 37320
- Hospital General de Leon
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Mexico City, Mexiko
- INCMNSZ
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44280
- Hospital Civil de Guadalajara
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Warsaw, Polen, 01-201
- Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
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Madrid, Spanien, 28046
- Hospital La Paz,
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Madrid, Spanien, 28805
- Hospital Principe de Asturias
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Malaga, Spanien, 29010
- Hospital Regional Carlos Haya De Malaga
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Seville, Spanien, 41013
- Virgen del Rocío University Hospital
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Valencia, Spanien, 46026
- Hospital Universitari i Politecnic La Fe
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Catalonia
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Badalona, Catalonia, Spanien, 08916
- Hospital Germans Trías i Pujol
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Barcelona, Catalonia, Spanien, 08036
- Hospital Clinic de Barcelona
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Barcelona, Catalonia, Spanien, 08041
- Hospital de La Santa Creu i Sant Pau
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London, Storbritannien, W2
- St. Mary's Hospital, Imperial College
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London, Storbritannien
- St. Thomas's Hospital
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Lothian
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Edinburgh, Lothian, Storbritannien
- Western General Hospital
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Sussex
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Brighton, Sussex, Storbritannien, BN21ES
- Brighton & Sussex University NHS Trust
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Warwickshire
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Coventry, Warwickshire, Storbritannien, CV 1 4FS
- Coventry and Warwickshire Partnership Trust
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Bangkok, Thailand, 10330
- Chulalongkorn University Hospital
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Berlin, Tyskland, 10777
- Gemeinschaftspraxis Jessen Jessen Stein
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Berlin, Tyskland, 13353
- Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
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Bonn, Tyskland, 53127
- University of Bonn, Med J. Immunologische Siudienzenirale
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Cologne, Tyskland, 50937
- Klinikum der Universität zu Köln
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Düsseldorf, Tyskland, 40225
- Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
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Hannover, Tyskland, 30625
- Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
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Frankfurt am Main
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Frankfurt, Frankfurt am Main, Tyskland, 60590
- Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: No change
continue their current cART regimen
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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
|
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.
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: 48 weeks after randomization
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48 weeks after randomization
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: David A Cooper, AO, Kirby Institute, University of New South Wales
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2011
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
28 juni 2011
Först inskickad som uppfyllde QC-kriterierna
28 juni 2011
Första postat (Uppskatta)
29 juni 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011-01-MAR
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .