Evidence map›Paper›PMID 27048747›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

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.

Sarah Lilian Pett, Janaki Amin, Andrejz Horban, Jaime Andrade-Villanueva, Marcelo Losso, Norma Porteiro, Juan Sierra Madero, Waldo Belloso, Elise Tu, David Silk and 19 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01384682 (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), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01384682 phase4completednot on this map

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

TypeinterventionalSponsorKirby InstituteRan2011 to 2015Enrolled399ConditionsHIVArmsMaraviroc
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
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  12. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors at 18 institutions in 12 countries.

Sarah Lilian PettThe Kirby Institute, University of New South Wales, Sydney, Australia Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology Clinical Research Group, Infection and Population Health, University College London, United Kingdom.
Janaki AminThe Kirby Institute, University of New South Wales, Sydney, Australia.
Andrejz HorbanWojewodzki Szpital Zakazny Centrum Diagnostyki i Terapii AIDS, Warsaw, Poland.
Jaime Andrade-VillanuevaHospital Civil de Guadalajara "Fray Antonio Alcalde," Jalisco, Mexico.
Marcelo LossoHospital General de Agudos J M Ramos Mejia Fundación IBIS Coordinacion de Investigacion Clinica Academica en Latinoamerica.
Norma PorteiroFundación Infectologia de Atencion Ambulatoria, Buenos Aires, Argentina.
Juan Sierra MaderoInstituto Nacional de Ciencias Medicas y Nutriciòn Salvador Zubiran, Tlalpan, Mexico.
Waldo BellosoFundación IBIS Coordinacion de Investigacion Clinica Academica en Latinoamerica Hospital Italiano de Buenos Aires, Argentina.
Elise TuThe Kirby Institute, University of New South Wales, Sydney, Australia.
David SilkThe Kirby Institute, University of New South Wales, Sydney, Australia.
Anthony KelleherThe Kirby Institute, University of New South Wales, Sydney, Australia St Vincent's Hospital, Sydney, Australia.
Richard HarriganBritish Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada.
Andrew ClarkViiV Healthcare Ltd, London, United Kingdom.
Wataru SugiuraNagoya Medical Centre, Japan.
Marcelo WolffFundacion Arriaran, Santiago, Chile.
John GillSouthern Alberta Clinic, Calgary, Canada.
Jose GatellHospital Clinic de Barcelona, Spain.
Martin FisherBrighton and Sussex University Hospitals National Health Service Trust, Brighton, United Kingdom.
Amanda ClarkeBrighton and Sussex University Hospitals National Health Service Trust, Brighton, United Kingdom.
Kiat RuxrungthamHIV Netherlands, Australia, Thailand Research Collaboration, Bangkok.
Thierry PrazuckOrleans Hospital (Centre Hospitalier Regional D'Orleans Orleans La Source), France.
Rolf KaiserInstitut für Virologie, Cologne, Germany.
Ian WoolleyMonash Medical Centre, Melbourne, Australia.
Juan Alberto ArnaizFundacion Clinic Spain Clinical Trials Unit, Barcelona.
David CooperThe Kirby Institute, University of New South Wales, Sydney, Australia St Vincent's Hospital, Sydney, Australia.
Jürgen K RockstrohDepartment of Medicine I, University Hospital Bonn, Germany.
Patrick MallonMater Misericordiae University Hospital, Dublin, Ireland.
Sean EmeryThe Kirby Institute, University of New South Wales, Sydney, Australia.
Maraviroc Switch (MARCH) Study Group
UNSW Sydney · AUUniversity Hospitals Sussex NHS Foundation Trust · GBAIDS Vancouver · CAAlberta Hip and Knee Clinic · CACentre hospitalier régional d'Orléans · FREstudios Clínicos Latinoamérica · ARFundacion Arriarán · CLHIV Netherlands Australia Thailand Research Collaboration · THHospital Civil de Guadalajara · MXHospital Clínic de Barcelona · ESHospital Italiano de Buenos Aires · ARInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXMater Misericordiae University Hospital · IEMonash Medical Centre · AUNagoya Medical Center · JPSt Vincent's Hospital Sydney · AUUniversity Hospital Bonn · DEViiV Healthcare (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlternative combination antiretroviral therapies in virologically suppressed human immunodeficiency virus (HIV)-infected patients experiencing side effects and/or at ongoing risk of important comorbidities from current therapy are needed. Maraviroc (MVC), a chemokine receptor 5 antagonist, is a potential alternative component of therapy in those with R5-tropic virus.

methodsThe Maraviroc Switch Study is a randomized, multicenter, 96-week, open-label switch study in HIV type 1-infected adults with R5-tropic virus, virologically suppressed on a ritonavir-boosted protease inhibitor (PI/r) plus double nucleoside/nucleotide reverse transcriptase inhibitor (2 N(t)RTI) backbone. Participants were randomized 1:2:2 to current combination antiretroviral therapy (control), or replacing the protease inhibitor (MVC + 2 N(t)RTI arm) or the nucleoside reverse transcriptase inhibitor backbone (MVC + PI/r arm) with twice-daily MVC. The primary endpoint was the difference (switch minus control) in proportion with plasma viral load (VL) <200 copies/mL at 48 weeks. The switch arms were judged noninferior if the lower limit of the 95% confidence interval (CI) for the difference in the primary endpoint was < -12% in the intention-to-treat (ITT) population.

resultsThe ITT population comprised 395 participants (control, n = 82; MVC + 2 N(t)RTI, n = 156; MVC + PI/r, n = 157). Baseline characteristics were well matched. At week 48, noninferior rates of virological suppression were observed in those switching away from a PI/r (93.6% [95% CI, -9.0% to 2.2%] and 91.7% [95% CI, -9.6% to 3.8%] with VL <200 and <50 copies/mL, respectively) compared to the control arm (97.6% and 95.1% with VL <200 and <50 copies/mL, respectively). In contrast, MVC + PI/r did not meet noninferiority bounds and was significantly inferior (84.1% [95% CI, -19.8% to -5.8%] and 77.7% [95% CI, -24.9% to -8.4%] with VL <200 and <50 copies/mL, respectively) to the control arm in the ITT analysis.

conclusionsThese data support MVC as a switch option for ritonavir-boosted PIs when partnered with a 2-N(t)RTI backbone, but not as part of N(t)RTI-sparing regimens comprising MVC with PI/r. CLINICAL TRIALS REGISTRATION: NCT01384682.

Indexed as

AdultComorbidityCyclohexanesFemaleHIV Fusion InhibitorsHIV InfectionsHIV Protease InhibitorsHumansMaleMaravirocMiddle AgedReverse Transcriptase InhibitorsRitonavirTreatment OutcomeTriazolesViral LoadCyclohexanesHIV Fusion InhibitorsHIV Protease InhibitorsMaravirocReverse Transcriptase InhibitorsRitonavirTriazolesantiretroviralcomorbidityHIV-1maravirocswitch

Identifiers

PMID27048747
PMCPMC5853584
OpenAlexW2385064459

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.