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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

386

Participants

Timeline

Start Date

April 22, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
HIV Infections
Interventions
DRUG

Dolutegravir (DTG) and lamivudine (3TC)

Children randomised to the DTG/3TC arm will receive once daily DTG/3TC fixed dose combination dispersible or film-coated tablets dosed using WHO weight bands criteria

DRUG

SOC

2 nucleos(t)ide reverse transcriptase inhibitor (NRTI) and a third (anchor) drug (either an integrase strand transfer inhibitor (INSTI), a protease inhibitor (PI) or a non- nucleoside reverse transcriptase inhibitor (NNRTI)

Trial Locations (14)

Unknown

King Edward VIII Hospital, Durban

PHRU Klerksdorp, Klerksdorp

PHRU, Soweto

Hospital Universitario 12 de Octubre, Madrid

Prapokklao Hospital, Chanthaburi

Nakornping Hospital, Chiang Mai

Chiangrai Prachanukroh Hospital, Chiang Rai

Khon Kaen Hospital, Khon Kaen

Baylor, Kampala

Joint Clinical Research Centre, Kampala

MUJHU, Kampala

Birmingham Heartlands Hospital, Birmingham

Great Ormand Street Hospital, London

St. Mary's Hospital, London

All Listed Sponsors
collaborator

MRC CTU at UCL

UNKNOWN

collaborator

AMS-CMU/IRD (PHPT)

UNKNOWN

collaborator

Chris Hani Baragwanath Academic Hospital

OTHER

collaborator

Durban International Clinical Research Site

UNKNOWN

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Prapokklao Hospital, Chantaburi

UNKNOWN

collaborator

Chiangrai Prachanukroh Hospital

OTHER

collaborator

Nakornping Hospital

OTHER

collaborator

Khon Kaen Hospital

OTHER_GOV

collaborator

Kalasin Hospital

OTHER

collaborator

Joint Clinical Research Center

OTHER

collaborator

MU-JHU CARE

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

collaborator

Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.

OTHER

collaborator

Advanced Pathogens Diagnostics Unit, University College London Hospitals

UNKNOWN

collaborator

Centre for Health Economics, University of York

UNKNOWN

collaborator

Department of Molecular and Clinical Pharmacology, University of Liverpool

UNKNOWN

collaborator

St Mary's NHS Trust

OTHER_GOV

collaborator

Chang Mai Univerity

UNKNOWN

lead

PENTA Foundation

NETWORK