D3
Research type
Research Study
Full 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
IRAS ID
1005245
Contact name
Anna Turkova
Contact email
Sponsor organisation
Fondazione Penta Onlus
Eudract number
2020-001426-57
ISRCTN Number
ISRCTN17157458
Clinicaltrials.gov Identifier
Research summary
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 DTG-based treatment with three anti-HIV medicines.
DTG is one kind of anti-HIV medicine that works very well and has few side effects. In international treatment guidelines it is one of the most highly recommended medicines for adults and young people who need to start anti-HIV medicines for the first time. 3TC is another anti-HIV medicine that is used in many HIV treatment regimens and has been shown to be very safe. Both medicines are taken once a day. Anti-HIV treatment using a two-medicine regimen including DTG and 3TC may offer treatment which is as safe and effective as a three-medicine regimen.
D3 will include 370 children and young people aged 2 to less than 15 years old who are living with HIV and are being treated with anti-HIV medicines for the first time. They will be split into two groups, by chance, by a process called “randomisation”. One group will receive DTG-based three-medicine treatment. The second group will change to the combination of two medicines, DTG and 3TC (with the combination written usually as “DTG/3TC”). Depending on their weight, those in the second group will be able take the new medicine either as one tablet a day or as a small number of dispersible tablets that are also taken once a day. All children and young people in the study will have regular clinic assessments that are at a similar frequency to the clinic visits that they would have outside of the study. Blood tests will be performed to check that the medicine is safe and, at some visits, participants and their carers will also be asked to answer some questions on how they feel about taking their medicine. We will follow all children and young people until the last participant who joins the study has been in the study for 96 weeks.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0298
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion