drugset / Trial / NCT04337450
DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old
Phase 2/3
Active not recruiting
386 enrolled
PENTA Foundation
AMS-CMU/IRD (PHPT) · collabAdvanced Pathogens Diagnostics Unit, University College London Hospitals · collabBaylor College of Medicine · collabCentre for Health Economics, University of York · collabChang Mai Univerity · collabChiangrai Prachanukroh Hospital · collabChris Hani Baragwanath Academic Hospital · collabDepartment of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands. · collabDepartment of Molecular and Clinical Pharmacology, University of Liverpool · collabDurban International Clinical Research Site · collabGreat Ormond Street Hospital for Children NHS Foundation Trust · collabHospital Universitario 12 de Octubre · collabJoint Clinical Research Center · collabKalasin Hospital · collabKhon Kaen Hospital · collabMRC CTU at UCL · collabMU-JHU CARE · collabNakornping Hospital · collabPrapokklao Hospital, Chantaburi · collabSt Mary's NHS Trust · collabUniversity Hospital Birmingham NHS Foundation Trust · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to find out whether treating children and young people living with HIV with two anti HIV medicines, dolutegravir and lamivudine, is safe and as effective as the three-medicine anti-HIV treatments currently used in routine practice.
Timeline
- Start
- 2022-04-22
- Primary completion
- 2025-09-30
- Completion
- 2026-09-30
Publications
- Turkova A, Chan MK, Kityo C, Kekitiinwa AR, Musoke P, Violari A, Variava E, Archary M, Cressey TR, Chalermpantmetagul S, Sawasdichai K, Ounchanum P, Kanjanavanit S, Srirojana S, Srirompotong U, Welch S, Bamford A, Epalza C, Fortuny C, Colbers A, Nastouli E, Walker S, Carr D, Conway M, Spyer MJ, Parkar N, White I, Nardone A, Thomason MJ, Ferrand RA, Giaquinto C, Ford D; D3 trial team. D3/Penta 21 clinical trial design: A randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years. Contemp Clin Trials. 2024 Jul;142:107540. doi: 10.1016/j.cct.2024.107540. Epub 2024 Apr 16.
- Botha JC, Byott M, Spyer MJ, Grant PR, Gartner K, Chen WX, Burton J, Bamford A, Waters LJ, Giaquinto C, Turkova A, Vavro CL, Nastouli E. Sensitive HIV-1 DNA Pol Next-Generation Sequencing for the Characterisation of Archived Antiretroviral Drug Resistance. Viruses. 2023 Aug 25;15(9):1811. doi: 10.3390/v15091811.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | — | — |
| Subject | Lamivudine | Other / unclassified | — | — |