D3

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

Is a new tablet that contains two medicines together, dolutegravir (DTG) and lamivudine (3TC), as good as the HIV medicines that children and young people currently take?

What is this study about?

This study aims to find out whether treating children and young people living with HIV with two anti-HIV medicines, dolutegravir (DTG) and lamivudine (3TC), is safe and as effective as dolutegravir-based treatment with three anti-HIV medicines.

 

 

 

 

Type of study

Randomised trial

Contact details

mrcctu.d3trial@ucl.ac.uk

Who is funding the study?

This trial is funded by ViiV Healthcare, with additional core funding support from the Medical Research Council.

When is it taking place?

D3 began in 2022 and completed recruitment in September 2023. Trial follow-up is expected to continue until 2025 and results are expected to be available in early-mid 2026.

Where is it taking place?

UK, South Africa, Spain, Thailand and Uganda.

Who is included?

Children living with HIV aged two to <15 years, weighing 6 kg or more and virologically suppressed on antiretroviral treatment for at least the last six months.