Once-daily dolutegravir/lamivudine fixed-dose formulations in children living with HIV: a pharmacokinetic and safety sub-study nested in the open-label, multicentre, randomised, non-inferiority D3/PENTA 21 trial.

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Title: Once-daily dolutegravir/lamivudine fixed-dose formulations in children living with HIV: a pharmacokinetic and safety sub-study nested in the open-label, multicentre, randomised, non-inferiority D3/PENTA 21 trial.
Authors: Bevers LAH; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: Lisanne.Bevers@radboudumc.nl., Toledo G; Medical Research Council Clinical Trials Unit at University College London, UK., Kisekka M; Baylor College of Medicine Children's Foundation, Kampala, Uganda., Kaudha E; Joint Clinical Research Centre, Kampala, Uganda., Ahimbisibwe GM; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda., Deprez I; GlaxoSmithKline, Mississauga, Canada; Certara, Princeton, NJ, USA., Arumugan T; Department of Paediatrics and Children Health, King Edward VIII Hospital, Enhancing Care Foundation, University of KwaZulu-Natal, Durban, South Africa., Variava E; Perinatal HIV Research Unit, University of the Witwarsrand, Johannesburg, South Africa., Violari A; Perinatal HIV Research Unit, University of the Witwarsrand, Johannesburg, South Africa., White I; Medical Research Council Clinical Trials Unit at University College London, UK., Bbuye D; Baylor College of Medicine Children's Foundation, Kampala, Uganda., Nanduudu A; Joint Clinical Research Centre, Kampala, Uganda., Mulwanyi E; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda., Amuge P; Baylor College of Medicine Children's Foundation, Kampala, Uganda., Rutebarika DA; Joint Clinical Research Centre, Kampala, Uganda., Kekitiinwa A; Baylor College of Medicine Children's Foundation, Kampala, Uganda., Kityo C; Joint Clinical Research Centre, Kampala, Uganda., Musoke P; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda., Archary M; Department of Paediatrics and Children Health, King Edward VIII Hospital, Enhancing Care Foundation, University of KwaZulu-Natal, Durban, South Africa., Boles J; ViiV Healthcare, London, UK., Thomason MJ; Medical Research Council Clinical Trials Unit at University College London, UK., de Wildt SN; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands; Department of Intensive Care, Radboud University Medical Center, Nijmegen, the Netherlands; Department of Neonatal and Pediatric Intensive Care, Erasmus MC Sophia Children's Hospital Rotterdam, the Netherlands., Giaquinto C; Department of Women and Child Health, Fondazione Penta ETS, University of Padova, Padova, Italy., Colbers A; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands., Burger DM; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands., Buchanan AM; ViiV Healthcare, Durham, NC, USA., Chan MK; Medical Research Council Clinical Trials Unit at University College London, UK., Jacobs TG; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: Tom.Jacobs@radboudumc.nl., Turkova A; Medical Research Council Clinical Trials Unit at University College London, UK.
Corporate Authors: D3 TRIAL TEAM
Source: EBioMedicine [EBioMedicine] 2025 Oct; Vol. 120, pp. 105929. Date of Electronic Publication: 2025 Sep 26.
Publication Type: Equivalence Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
Journal Info: Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101647039 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2352-3964 (Electronic) Linking ISSN: 23523964 NLM ISO Abbreviation: EBioMedicine Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:2352-3964
DOI:10.1016/j.ebiom.2025.105929