{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T02:09:02Z","timestamp":1785550142112,"version":"3.56.0"},"reference-count":65,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T00:00:00Z","timestamp":1770249600000},"content-version":"unspecified","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","award":["101190925"],"award-info":[{"award-number":["101190925"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003323","name":"Agence Nationale de Recherches sur le Sida et les H\u00e9patites Virales","doi-asserted-by":"publisher","award":["ANRS0392s"],"award-info":[{"award-number":["ANRS0392s"]}],"id":[{"id":"10.13039\/501100003323","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016912","name":"Merck Sharp and Dohme France","doi-asserted-by":"publisher","award":["IIS# 101575"],"award-info":[{"award-number":["IIS# 101575"]}],"id":[{"id":"10.13039\/100016912","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,1,21]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain and potentially also with cardiometabolic disorders. In an effort to expand therapeutic options for people living with HIV (PLHIV), the EvaLuating the non-inferiority of DORAvirine vs DOlutegravir trial aims to compare the virologic efficacy of doravirine (DOR) and DTG-based regimens and to assess their safety, including a focus on cardiometabolic effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is an international, phase III, multicentre, open-label, non-inferiority, randomised trial that will enrol 610 ART-na\u00efve PLHIV (HIV RNA\u22651000 copies\/mL at screening) across six countries (Brazil, Cameroon, France, C\u00f4te d\u2019Ivoire, Mozambique and Thailand) spanning four continents. Key inclusion criteria include age \u226518 years, confirmed HIV-1 infection with plasma RNA levels \u22651000 copies\/mL, indication for ART initiation and no prior ART exposure. Participants will be randomised in a 1:1 ratio to receive either DOR 100\u2009mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300\u2009mg daily) plus lamivudine (3TC) (300\u2009mg daily) or DTG (50\u2009mg daily) in combination with TDF (300\u2009mg once daily) plus either emtricitabine (FTC) (200\u2009mg daily) or 3TC (300\u2009mg daily). Randomisation will be stratified by screening HIV-1 RNA load (\u2264100\u2009000\u2009or &gt;100\u2009000 copies\/mL) and by country. The primary outcome is virological efficacy, defined as the proportion of participants achieving HIV-1 RNA &lt;50 copies\/mL at week 48 on the assigned treatment (FDA Snapshot algorithm). Secondary outcomes include cardiometabolic safety endpoints (ie, weight gain, insulin resistance, hypertension, diabetes, waist and hip circumferences, waist-to-hip ratio, fasting glycaemia, insulin and fasting serum lipids), along with mental health, quality of life, virological and immunological parameters. Final data collection is expected by July 2028.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Primary outcome results (week 48) are expected in early 2028. The project was submitted to and approved by national ethics committees and pharmaceutical regulatory authorities in all participating countries: Brazil (CEP INI FIOCRUZ (21.040-900)\/CEP HGNI (26.030-380)); Cameroon (CNERSH (2024\/09\/1717\/CE\/CNERSH\/SP)\/Ministry of Public Health (D30-1464\/AAR\/MINSANTE\/SG\/DROS\/CRC); C\u00f4te d'Ivoire: (CNESVS (0018224\/MSHPCMU\/CNESVS-km)\/AIRP (1329\/AIRP\/DISMP\/Om\/kbaag); France (CTIS CPP\/ANSM (2023-508626-10-00)); Mozambique (CNBS (20\/CNBS\/25)\/ANARME (4635\/380\/ANARME)); Thailand: (IHRP (08\/1944)\/Thai FDA: ongoing on 19 January 2026). The trial received authorisation from the French National Commission for Data Protection and Liberties (CNIL) under approval number 924\u2009302. Written informed consent is obtained from all participants prior to any study-specific procedures and trial enrolment, in accordance with the Declaration of Helsinki and applicable national regulations. Study findings will be disseminated through publication in peer-reviewed journals and presentations at national and international scientific conferences. Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration numbers<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06203132\">NCT06203132<\/jats:ext-link>\n                      ; EU-CT, 2023-508626-10-00.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-110560","type":"journal-article","created":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T13:51:17Z","timestamp":1770299477000},"page":"e110560","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06203132","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06203132","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0069-3332","authenticated-orcid":false,"given":"Anthony","family":"L\u2019hostellier","sequence":"first","affiliation":[{"name":"National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Center, University of Bordeaux, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Kouanfack","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Pharmaceutical Sciences, Universit\u00e9 de Dschang, Yaounde, Cameroon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corine","family":"Chazallon","sequence":"additional","affiliation":[{"name":"National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Research Center, University of Bordeaux, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Wagner-Cardoso","sequence":"additional","affiliation":[{"name":"STDs\/AIDS Clinical Research Laboratory, Oswaldo Cruz Foundation, National Institute of Infectology (INI), Rio de Janeiro, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serge Paul","family":"Eholie","sequence":"additional","affiliation":[{"name":"Department of Infectious and Tropical Diseases, CHU de Treichville, Abidjan, C\u00f4te d\u2019Ivoire"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neiva","family":"Banze","sequence":"additional","affiliation":[{"name":"Instituto Nacional de Sa\u00fade, Maputo, Mozambique"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guttiga","family":"Halue","sequence":"additional","affiliation":[{"name":"Internal Medicine Department, Department of Medical, Phayao Hospital, Mueang Phayao District, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1710-4186","authenticated-orcid":false,"given":"Jacqueline","family":"Capeau","sequence":"additional","affiliation":[{"name":"Inserm UMR_S938, CRSA, ICAN, Sorbonne Universite, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Constance","family":"Delaugerre","sequence":"additional","affiliation":[{"name":"Virology Department, Assistance Publique - 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