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Maraviroc Switch Collaborative Study (MARCH)

2016年1月18日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

399

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2R OX7
        • Southern Alberta Clinic
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2N2
        • University Health Network/Toronto General Hospital
      • Toronto、Ontario、加拿大、ON M5G 1k2
        • Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
    • Quebec
      • Montreal、Quebec、加拿大、H3A 1T1
        • Clinic Opus/Lori
  • 墨西哥
      • Leon、墨西哥、37320
        • Hospital General de Leon
      • Mexico City、墨西哥
        • INCMNSZ
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44280
        • Hospital Civil de Guadalajara
  • 德国
      • Berlin、德国、10777
        • Gemeinschaftspraxis Jessen Jessen Stein
      • Berlin、德国、13353
        • Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
      • Bonn、德国、53127
        • University of Bonn, Med J. Immunologische Siudienzenirale
      • Cologne、德国、50937
        • Klinikum der Universität zu Köln
      • Düsseldorf、德国、40225
        • Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
      • Hannover、德国、30625
        • Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
    • Frankfurt am Main
      • Frankfurt、Frankfurt am Main、德国、60590
        • Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
  • 日本
      • Nagoya、日本、460-0001
        • Nagoya Medical Center
  • 智利
    • Santiago RM
      • Santiago、Santiago RM、智利
        • Fundacion Arriaran
  • 法国
      • Orleans、法国、45100
        • Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
  • 波兰
      • Warsaw、波兰、01-201
        • Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
  • 泰国
      • Bangkok、泰国、10330
        • Chulalongkorn University Hospital
  • 澳大利亚
    • New South Wales
      • Sydney、New South Wales、澳大利亚、2010
        • Holdsworth House Medical Practice
      • Sydney、New South Wales、澳大利亚、2145
        • Westmead Hospital
      • Sydney、New South Wales、澳大利亚、2050
        • Royal Prince Alfred Hospital
      • Sydney、New South Wales、澳大利亚、2010
        • St. Vincent's Hospital
    • Queensland
      • Bisbane、Queensland、澳大利亚、4101
        • Gladstone Road Medical Centre
      • Brisbane、Queensland、澳大利亚、4000
        • Brisbane Sexual Health and HIV Service (formerly AMU)
      • Nambour、Queensland、澳大利亚、4560
        • Nambour General Hospital
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • O'Brien Street Practice
    • Victoria
      • Melbourne、Victoria、澳大利亚、3168
        • Monash Medical Centre
      • Melbourne、Victoria、澳大利亚、3004
        • Alfred Hospital
  • 爱尔兰
      • Dublin、爱尔兰、7
        • Mater Misericordiae University Hospital
  • 英国
      • London、英国、W2
        • St. Mary's Hospital, Imperial College
      • London、英国
        • St. Thomas's Hospital
    • Lothian
      • Edinburgh、Lothian、英国
        • Western General Hospital
    • Sussex
      • Brighton、Sussex、英国、BN21ES
        • Brighton & Sussex University NHS Trust
    • Warwickshire
      • Coventry、Warwickshire、英国、CV 1 4FS
        • Coventry and Warwickshire Partnership Trust
  • 西班牙
      • Madrid、西班牙、28046
        • Hospital La Paz,
      • Madrid、西班牙、28805
        • Hospital Principe de Asturias
      • Malaga、西班牙、29010
        • Hospital Regional Carlos Haya De Malaga
      • Seville、西班牙、41013
        • Virgen del Rocío University Hospital
      • Valencia、西班牙、46026
        • Hospital Universitari i Politecnic La Fe
    • Catalonia
      • Badalona、Catalonia、西班牙、08916
        • Hospital Germans Trías i Pujol
      • Barcelona、Catalonia、西班牙、08036
        • Hospital Clinic de Barcelona
      • Barcelona、Catalonia、西班牙、08041
        • Hospital de La Santa Creu i Sant Pau
  • 阿根廷
      • Buenos Aires、阿根廷、C1405CKC
        • Fundacion IDEAA
      • Cordoba、阿根廷
        • Hospital Privado- Centro Medico Cordoba
    • Ciudad de Buenos Aires
      • Buenos Aires、Ciudad de Buenos Aires、阿根廷、1425
        • FUNCEI
      • Buenos Aires、Ciudad de Buenos Aires、阿根廷、C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires、Ciudad de Buenos Aires、阿根廷、C1221ADC
        • Hospital G de Agudos JM Ramos Mejia
    • Provincia de Buenos Aires
      • El Palomar、Provincia de Buenos Aires、阿根廷、1684
        • Hospital Nacional Prof Alejandro Posadas
      • Isidro Casanova、Provincia de Buenos Aires、阿根廷、1765
        • Hospital Dr Diego Paroissien
    • Provincia de Santa Fe
      • Rosario、Provincia de Santa Fe、阿根廷、S2000PBJ
        • CAICI

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：No change
continue their current cART regimen
有源比较器：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
药品：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.
有源比较器：Replace PI/r drugs with Maraviroc
Replace PI/r drugs with MVC at a dose of 300mg bid and continue 2N(t)RTI.
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
大体时间：48 weeks after randomization
48 weeks after randomization

次要结果测量

结果测量
措施说明
大体时间
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kirby Institute

合作者

Pfizer
ViiV Healthcare

调查人员

  • 首席研究员：David A Cooper, AO、Kirby Institute, University of New South Wales

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年8月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2011年6月28日

首先提交符合 QC 标准的

2011年6月28日

首次发布 (估计)

2011年6月29日

研究记录更新

最后更新发布 (估计)

2016年1月20日

上次提交的符合 QC 标准的更新

2016年1月18日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2011-01-MAR

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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