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.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Dublin、アイルランド、7
- Mater Misericordiae University Hospital
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Buenos Aires、アルゼンチン、C1405CKC
- Fundacion IDEAA
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Cordoba、アルゼンチン
- Hospital Privado- Centro Medico Cordoba
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Ciudad de Buenos Aires
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Buenos Aires、Ciudad de Buenos Aires、アルゼンチン、1425
- FUNCEI
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Buenos Aires、Ciudad de Buenos Aires、アルゼンチン、C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires、Ciudad de Buenos Aires、アルゼンチン、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、アルゼンチン、1684
- Hospital Nacional Prof Alejandro Posadas
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Isidro Casanova、Provincia de Buenos Aires、アルゼンチン、1765
- Hospital Dr Diego Paroissien
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Provincia de Santa Fe
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Rosario、Provincia de Santa Fe、アルゼンチン、S2000PBJ
- CAICI
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London、イギリス、W2
- St. Mary's Hospital, Imperial College
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London、イギリス
- St. Thomas's Hospital
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Lothian
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Edinburgh、Lothian、イギリス
- Western General Hospital
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Sussex
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Brighton、Sussex、イギリス、BN21ES
- Brighton & Sussex University NHS Trust
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Warwickshire
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Coventry、Warwickshire、イギリス、CV 1 4FS
- Coventry and Warwickshire Partnership Trust
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New South Wales
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Sydney、New South Wales、オーストラリア、2010
- Holdsworth House Medical Practice
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Sydney、New South Wales、オーストラリア、2145
- Westmead Hospital
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Sydney、New South Wales、オーストラリア、2050
- Royal Prince Alfred Hospital
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Sydney、New South Wales、オーストラリア、2010
- St. Vincent's Hospital
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Queensland
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Bisbane、Queensland、オーストラリア、4101
- Gladstone Road Medical Centre
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Brisbane、Queensland、オーストラリア、4000
- Brisbane Sexual Health and HIV Service (formerly AMU)
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Nambour、Queensland、オーストラリア、4560
- Nambour General Hospital
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- O'Brien Street Practice
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Victoria
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Melbourne、Victoria、オーストラリア、3168
- Monash Medical Centre
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Melbourne、Victoria、オーストラリア、3004
- Alfred Hospital
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Alberta
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Calgary、Alberta、カナダ、T2R OX7
- Southern Alberta Clinic
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Ontario
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Toronto、Ontario、カナダ、M5G 2N2
- University Health Network/Toronto General Hospital
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Toronto、Ontario、カナダ、ON M5G 1k2
- Canadian Immunodeficiency Research Collaborative (CIRC) lnc (Maple Leaf Clinic)
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Quebec
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Montreal、Quebec、カナダ、H3A 1T1
- Clinic Opus/Lori
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Madrid、スペイン、28046
- Hospital La Paz,
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Madrid、スペイン、28805
- Hospital Principe de Asturias
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Malaga、スペイン、29010
- Hospital Regional Carlos Haya De Malaga
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Seville、スペイン、41013
- Virgen del Rocío University Hospital
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Valencia、スペイン、46026
- Hospital Universitari i Politecnic La Fe
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Catalonia
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Badalona、Catalonia、スペイン、08916
- Hospital Germans Trias i Pujol
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Barcelona、Catalonia、スペイン、08036
- Hospital Clínic de Barcelona
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Barcelona、Catalonia、スペイン、08041
- Hospital de la Santa Creu i Sant Pau
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Bangkok、タイ、10330
- Chulalongkorn University Hospital
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Santiago RM
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Santiago、Santiago RM、チリ
- Fundacion Arriaran
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Berlin、ドイツ、10777
- Gemeinschaftspraxis Jessen Jessen Stein
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Berlin、ドイツ、13353
- Dienstleistung centre ID (Baumgarten, MIB medical center for infectious diseases)
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Bonn、ドイツ、53127
- University of Bonn, Med J. Immunologische Siudienzenirale
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Cologne、ドイツ、50937
- Klinikum der Universität zu Köln
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Düsseldorf、ドイツ、40225
- Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie-MX- Amb
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Hannover、ドイツ、30625
- Klinik für Immunologie und Rheumatologie, Medzinische Hochschule Hannover
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Frankfurt am Main
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Frankfurt、Frankfurt am Main、ドイツ、60590
- Johann Wolfgang Goethe-University Hospital, Medical HIVCENTER
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Orleans、フランス、45100
- Service Maladies infectieuses et Tropicales CHR ORLEANS La SOURCE
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Warsaw、ポーランド、01-201
- Wojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS
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Leon、メキシコ、37320
- Hospital General de León
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Mexico City、メキシコ
- INCMNSZ
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Jalisco
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Guadalajara、Jalisco、メキシコ、44280
- Hospital Civil de Guadalajara
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Nagoya、日本、460-0001
- Nagoya Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:No change
continue their current cART regimen
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アクティブコンパレータ: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.
|
アクティブコンパレータ: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
The comparison of the switch arms to control arm of proportions of participants with HIV RNA <200 copies/mL 48 weeks after randomisation.
時間枠:48 weeks after randomization
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48 weeks after randomization
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Virological endpoints: proportion of participants with plasma HIV-1 RNA<50 copies/ml
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:David A Cooper, AO、Kirby Institute, University of New South Wales
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2011-01-MAR
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HIVの臨床試験
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public Health募集HIV | HIV検査 | HIV とケアの関係 | HIV治療アメリカ
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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University of Minnesota引きこもったHIV感染症 | HIV/エイズ | HIV | AIDS | エイズ・HIV問題 | エイズと感染症アメリカ
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University of Southampton と他の協力者募集
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur... と他の協力者わからないHIV | HIVに感染していない子供たち | HIVにさらされた子供たちカメルーン
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
-
Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集
Maravirocの臨床試験
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Asociacion para el Estudio de las Enfermedades...完了