Interventional Active not recruiting Phase 2/Phase 3
NCT04337450 on ClinicalTrials.gov
DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old
Official title: A Randomised Non-inferiority Trial With Nested PK to Assess DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old
- 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
- Enrollment: 386 (Actual)
- Study start: 2022-04-22 (Actual)
- Primary completion: 2025-09-30 (Actual)
- Study completion: 2026-09-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief 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.
Conditions
- HIV Infections
Intervention / Treatment
- Drug: Dolutegravir (DTG) and lamivudine (3TC)
- Drug: SOC
Primary Outcome Measures
- Proportion of children with confirmed viral rebound (defined as the first of two consecutive HIV-1 RNA ≥50c/mL) by week 96 (by Week 96)
Countries
South Africa, Spain, Thailand, Uganda, United Kingdom
Locations and Investigators
-
Hospital Universitario 12 De Octubre, Madrid, Spain
- Pablo, Rojo
-
Hospital Sant Joan De Deu Barcelona, Esplugues De Llobregat, Spain
- Clà udia, Fortuny