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

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

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)

Sponsors & Collaborators

• MRC CTU at UCL

  collaborator UNKNOWN

• AMS-CMU/IRD (PHPT)

  collaborator UNKNOWN

• Chris Hani Baragwanath Academic Hospital

  collaborator OTHER

• Durban International Clinical Research Site

  collaborator UNKNOWN

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Prapokklao Hospital, Chantaburi

  collaborator UNKNOWN

• Chiangrai Prachanukroh Hospital

  collaborator OTHER

• Nakornping Hospital

  collaborator OTHER

• Khon Kaen Hospital

  collaborator OTHER_GOV

• Kalasin Hospital

  collaborator OTHER

• Joint Clinical Research Center

  collaborator OTHER

• MU-JHU CARE

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

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

  collaborator OTHER

• Advanced Pathogens Diagnostics Unit, University College London Hospitals

  collaborator UNKNOWN

• Centre for Health Economics, University of York

  collaborator UNKNOWN

• Department of Molecular and Clinical Pharmacology, University of Liverpool

  collaborator UNKNOWN

• St Mary's NHS Trust

  collaborator OTHER_GOV

• Chang Mai Univerity

  collaborator UNKNOWN

• PENTA Foundation

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-22

Primary Completion

2025-09-30

Completion

2026-09-30

Countries

• South Africa
• Spain
• Thailand
• Uganda
• United Kingdom

Study Locations