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. |
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| 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 |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 41014973 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Bevers+LAH%22">Bevers LAH</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Toledo+G%22">Toledo G</searchLink>; Medical Research Council Clinical Trials Unit at University College London, UK.<br /><searchLink fieldCode="AU" term="%22Kisekka+M%22">Kisekka M</searchLink>; Baylor College of Medicine Children's Foundation, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Kaudha+E%22">Kaudha E</searchLink>; Joint Clinical Research Centre, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Ahimbisibwe+GM%22">Ahimbisibwe GM</searchLink>; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Deprez+I%22">Deprez I</searchLink>; GlaxoSmithKline, Mississauga, Canada; Certara, Princeton, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Arumugan+T%22">Arumugan T</searchLink>; Department of Paediatrics and Children Health, King Edward VIII Hospital, Enhancing Care Foundation, University of KwaZulu-Natal, Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Variava+E%22">Variava E</searchLink>; Perinatal HIV Research Unit, University of the Witwarsrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22Violari+A%22">Violari A</searchLink>; Perinatal HIV Research Unit, University of the Witwarsrand, Johannesburg, South Africa.<br /><searchLink fieldCode="AU" term="%22White+I%22">White I</searchLink>; Medical Research Council Clinical Trials Unit at University College London, UK.<br /><searchLink fieldCode="AU" term="%22Bbuye+D%22">Bbuye D</searchLink>; Baylor College of Medicine Children's Foundation, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Nanduudu+A%22">Nanduudu A</searchLink>; Joint Clinical Research Centre, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Mulwanyi+E%22">Mulwanyi E</searchLink>; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Amuge+P%22">Amuge P</searchLink>; Baylor College of Medicine Children's Foundation, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Rutebarika+DA%22">Rutebarika DA</searchLink>; Joint Clinical Research Centre, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Kekitiinwa+A%22">Kekitiinwa A</searchLink>; Baylor College of Medicine Children's Foundation, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Kityo+C%22">Kityo C</searchLink>; Joint Clinical Research Centre, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Musoke+P%22">Musoke P</searchLink>; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda.<br /><searchLink fieldCode="AU" term="%22Archary+M%22">Archary M</searchLink>; Department of Paediatrics and Children Health, King Edward VIII Hospital, Enhancing Care Foundation, University of KwaZulu-Natal, Durban, South Africa.<br /><searchLink fieldCode="AU" term="%22Boles+J%22">Boles J</searchLink>; ViiV Healthcare, London, UK.<br /><searchLink fieldCode="AU" term="%22Thomason+MJ%22">Thomason MJ</searchLink>; Medical Research Council Clinical Trials Unit at University College London, UK.<br /><searchLink fieldCode="AU" term="%22de+Wildt+SN%22">de Wildt SN</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Giaquinto+C%22">Giaquinto C</searchLink>; Department of Women and Child Health, Fondazione Penta ETS, University of Padova, Padova, Italy.<br /><searchLink fieldCode="AU" term="%22Colbers+A%22">Colbers A</searchLink>; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Burger+DM%22">Burger DM</searchLink>; Department of Pharmacy, Pharmacology and Toxicology, Radboudumc Research Institute for Medical Innovation (RIMI), Radboud University Medical Center, Nijmegen, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Buchanan+AM%22">Buchanan AM</searchLink>; ViiV Healthcare, Durham, NC, USA.<br /><searchLink fieldCode="AU" term="%22Chan+MK%22">Chan MK</searchLink>; Medical Research Council Clinical Trials Unit at University College London, UK.<br /><searchLink fieldCode="AU" term="%22Jacobs+TG%22">Jacobs TG</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Turkova+A%22">Turkova A</searchLink>; Medical Research Council Clinical Trials Unit at University College London, UK. – Name: AuthorCorporate Label: Corporate Authors Group: Au Data: <searchLink fieldCode="CA" term="%22D3+TRIAL+TEAM%22">D3 TRIAL TEAM</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101647039%22">EBioMedicine</searchLink> [EBioMedicine] 2025 Oct; Vol. 120, pp. 105929. <i>Date of Electronic Publication: </i>2025 Sep 26. – Name: TypePub Label: Publication Type Group: TypPub Data: Equivalence Trial; Journal Article; Multicenter Study; Randomized Controlled Trial – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+B%2EV%22">Elsevier B.V </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>101647039 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2352-3964 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2223523964%22">23523964 </searchLink><i>NLM ISO Abbreviation: </i>EBioMedicine <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=41014973 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/j.ebiom.2025.105929 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 105929 Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Bevers LAH – PersonEntity: Name: NameFull: Toledo G – PersonEntity: Name: NameFull: Kisekka M – PersonEntity: Name: NameFull: Kaudha E – PersonEntity: Name: NameFull: Ahimbisibwe GM – PersonEntity: Name: NameFull: Deprez I – PersonEntity: Name: NameFull: Arumugan T – PersonEntity: Name: NameFull: Variava E – PersonEntity: Name: NameFull: Violari A – PersonEntity: Name: NameFull: White I – PersonEntity: Name: NameFull: Bbuye D – PersonEntity: Name: NameFull: Nanduudu A – PersonEntity: Name: NameFull: Mulwanyi E – PersonEntity: Name: NameFull: Amuge P – PersonEntity: Name: NameFull: Rutebarika DA – PersonEntity: Name: NameFull: Kekitiinwa A – PersonEntity: Name: NameFull: Kityo C – PersonEntity: Name: NameFull: Musoke P – PersonEntity: Name: NameFull: Archary M – PersonEntity: Name: NameFull: Boles J – PersonEntity: Name: NameFull: Thomason MJ – PersonEntity: Name: NameFull: de Wildt SN – PersonEntity: Name: NameFull: Giaquinto C – PersonEntity: Name: NameFull: Colbers A – PersonEntity: Name: NameFull: Burger DM – PersonEntity: Name: NameFull: Buchanan AM – PersonEntity: Name: NameFull: Chan MK – PersonEntity: Name: NameFull: Jacobs TG – PersonEntity: Name: NameFull: Turkova A IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 10 Text: 2025 Oct Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 2352-3964 Numbering: – Type: volume Value: 120 Titles: – TitleFull: EBioMedicine Type: main |
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