Clinical Trial

DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old

Study acronym: D3 (Penta21)
Active, Not Recruiting Phase 2/3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-04-06; most recent amendment 2026-03-03.
Status change: Recruiting → Active, Not Recruiting 2025-03-28
Status change: Not Yet Recruiting → Recruiting 2023-08-01
Trial Details
NCT Number NCT04337450
Lead Sponsor PENTA Foundation
Collaborators: MRC CTU at UCL, AMS-CMU/IRD (PHPT), Chris Hani Baragwanath Academic Hospital, Durban International Clinical Research Site, Hospital Universitario 12 de Octubre, Prapokklao Hospital, Chantaburi, Chiangrai Prachanukroh Hospital, Nakornping Hospital, Khon Kaen Hospital, Kalasin Hospital, Joint Clinical Research Center, MU-JHU CARE, Baylor College of Medicine, Great Ormond Street Hospital for Children NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands., Advanced Pathogens Diagnostics Unit, University College London Hospitals, Centre for Health Economics, University of York, Department of Molecular and Clinical Pharmacology, University of Liverpool, St Mary's NHS Trust, Chang Mai Univerity
Conditions HIV Infections
Enrollment 386 participants
Start Date 2022-04-22
Primary Completion 2025-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-04