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Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions

dc.rights.licenseopenen_US
dc.contributor.authorMOORE, C. L.
dc.contributor.authorSTOHR, W.
dc.contributor.authorCROOK, A. M.
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorLELIEVRE, J. D.
dc.contributor.authorPANTALEO, G.
dc.contributor.authorGARCIA, F.
dc.contributor.authorVELLA, S.
dc.contributor.authorLEVY, Y.
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorTHIEBAUT, Rodolphe
dc.contributor.authorMCCORMACK, S.
dc.date.accessioned2020-07-01T08:49:52Z
dc.date.available2020-07-01T08:49:52Z
dc.date.issued2019-05
dc.identifier.issn2352-3018en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/8372
dc.description.abstractEnThe evaluation of immune-based approaches to achieve an antiretroviral therapy free remission of HIV infection requires proven efficacy through antiretroviral therapy interruption placebo-controlled trials. This approach is not without risk to participants and innovative trial designs need to be developed that minimise the number of participants treated with placebo and ineffective candidates. Multi-arm, multi-stage (MAMS) trial designs can be used in this context to accelerate the development of an immune-based therapeutic agent for HIV cure. Issues related to implementing a MAMS design within the planned EHVA T01 trial are considered here. EHVA T01 is a multicentre, MAMS, double-blind, phase 1 and 2 trial that aims to evaluate the effect of immune interventions on viral control in HIV-1 infected participants following analytic treatment interruption. The application of a MAMS design increases the likelihood that the EHVA T01 trial will identify a successful treatment and minimises the number of participants undergoing analytical treatment interruptions who have been treated with futile agents. The use of a MAMS design is a promising strategy to evaluate complex immune-based approaches aimed at curing HIV-infection, particularly relevant to the pipeline with multiple agents requiring examination.
dc.language.isoENen_US
dc.subject.enSISTM
dc.title.enMulti-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions
dc.title.alternativeLancet HIVen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/s2352-3018(19)30082-7en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed31047670en_US
bordeaux.journalThe Lancet HIVen_US
bordeaux.pagee334-e340en_US
bordeaux.volume6en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue5en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamSISTM_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03160751
hal.version1
hal.date.transferred2021-03-05T13:46:55Z
hal.exporttrue
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