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Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial

dc.rights.licenseopenen_US
dc.contributor.authorBALLIF, Marie
dc.contributor.authorBRAUN, Dominique
dc.contributor.authorCALMY, Alexandra
dc.contributor.authorBERNASCONI, Enos
dc.contributor.authorCAVASSINI, Matthias
dc.contributor.authorTISSOT, Frédéric
dc.contributor.authorSTOECKLE, Marcel
dc.contributor.authorSCHMID, Patrick
dc.contributor.authorFUX, Christoph A
dc.contributor.authorVAN DER VALK, Marc
dc.contributor.authorBRINKMAN, Kees
dc.contributor.authorMUDRIKOVA, Tania
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorBONNET, Fabrice
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLELEUX, Olivier
dc.contributor.authorSAÚDE, Manuela
dc.contributor.authorHIRTER, Daniela
dc.contributor.authorSCHWAB, Nathalie
dc.contributor.authorLIMACHER, Andreas
dc.contributor.authorRINTELEN, Felix
dc.contributor.authorKOUYOS, Roger
dc.contributor.authorHAERRY, David
dc.contributor.authorZAMBRANO, Sofia C
dc.contributor.authorEGLOFF, Martina
dc.contributor.authorAKRE, Christina
dc.contributor.authorPEYTREMANN-BRIDEVAUX, Isabelle
dc.contributor.authorRAUCH, Andri
dc.contributor.authorWANDELER, Gilles
dc.contributor.authorSURIAL, Bernard
dc.date.accessioned2025-01-21T14:22:38Z
dc.date.available2025-01-21T14:22:38Z
dc.date.issued2024-11-21
dc.identifier.issn2044-6055en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/204454
dc.description.abstractEnAnti-retroviral therapy (ART) simplification strategies are needed for treatment-experienced people with HIV (PWH) and multidrug-resistant viruses. These individuals are commonly treated with boosted ART regimens and are thereby at risk for harmful drug-drug interactions (DDI). In this trial, we aim to assess the efficacy of the combination doravirine, dolutegravir and lamivudine (DOR/DTG/3TC) among people with a history of virological failure who receive boosted ART. B-Free is a multistage, randomised, multicentre, open-label, non-inferiority trial, embedded within the Swiss HIV Cohort Study and conducted in collaboration with cohorts of PWH in the Netherlands and France. Cohort participants with a history of ART change due to virologic failure and who maintain HIV virologic suppression with an ART regimen consisting of a pharmacological booster and at least two drugs from classes other than nucleoside reverse transcriptase inhibitors are included. Patients with major drug resistance mutations against DTG or DOR and individuals with chronic hepatitis B virus infection are not eligible for the study. Individuals are randomised 1:1 to either receiving co-formulated DTG/3TC and DOR once daily or continuing their boosted ART regimen. The primary outcome is the proportion of individuals lacking virologic control (HIV-RNA ≥50 cp/mL) at 48 weeks, according to the Food and Drug Administration snapshot algorithm. Changes in DDI burden (assessed using a DDI score), treatment satisfaction (assessed using the HIV Treatment Satisfaction Questionnaire), quality of life and mental health represent key secondary outcomes. Additional secondary outcomes include the proportion of individuals developing new resistance-associated mutations and changes in quality of life and mental health. In a qualitative substudy, we will conduct semistructured interviews with a subset of participants to assess their expectations and experiences towards HIV treatment and clinical research in general. Enrolling 210 individuals will provide 80% power to demonstrate non-inferiority, defined as less than 8% absolute increase in loss of viral suppression in individuals randomised to DOR/DTG/3TC (one-sided type I error rate of 0.025). The study was approved by the competent ethics committees (reference number BASEC 2023-01060) and the regulatory authority Swissmedic (reference number 701655) in Switzerland before the enrolment of the first participant. Approval by the European Medicines Agency and local ethical committees in the Netherlands and France will be obtained prior to including participants in these countries. Participant's written informed consent is obtained by the investigators before enrolment. The results of all major B-Free study outcomes will be submitted to peer-reviewed journals that enable Open Access publication. Swiss National Clinical Trials Portal (SNCTP000005686, registered on 06 November 2023) and Clinicaltrials.gov (NCT06037564, registered on 07 September 2023).
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enHumans
dc.subject.enAnti-HIV Agents
dc.subject.enDrug Resistance
dc.subject.enMultiple
dc.subject.enViral
dc.subject.enEquivalence Trials as Topic
dc.subject.enFrance
dc.subject.enHeterocyclic Compounds
dc.subject.en3-Ring
dc.subject.enHIV Infections
dc.subject.enLamivudine
dc.subject.enMulticenter Studies as Topic
dc.subject.enNetherlands
dc.subject.enOxazines
dc.subject.enPiperazines
dc.subject.enPyridones
dc.subject.enQuality of Life
dc.subject.enRandomized Controlled Trials as Topic
dc.subject.enSwitzerland
dc.subject.enViral Load
dc.title.enBooster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial
dc.title.alternativeBMJ Openen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1136/bmjopen-2024-094912en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed39578038en_US
bordeaux.journalBMJ Openen_US
bordeaux.pagee094912en_US
bordeaux.volume14en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue11en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut de Recherche pour le Développementen_US
bordeaux.import.sourcepubmed
hal.identifierhal-04904029
hal.version1
hal.date.transferred2025-01-21T14:22:42Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
workflow.import.sourcepubmed
dc.rights.ccPas de Licence CCen_US
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