D3

D3 (PENTA 21)

HIV infection implies taking medicines for life. Therefore, it is important that they not only work well, but also that they continue to be safe, with a low chance of long-term side effects, and that they are easy to take every day. Anti-HIV treatment using two medicines instead of three may be one way of achieving this. 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 the three-medicine anti-HIV treatments currently used in routine practice.

What is D3?

What is D3?

D3 (PENTA 21): 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

D3 is looking to see if a new tablet whether a combination of two anti HIV medicines, DTG and 3TC, are as good as and effective in treating HIV in children and young people living with HIV in comparison to the current anti HIV medicines available. The trial will include 370 children and young people from South Africa, Spain, Thailand, Uganda and the UK. Penta is the sponsor the D3 trial.

Why is D3 needed?

Why is D3 needed?

Life-long anti HIV medication presents new challenges of treatment fatigue and long-term toxicities, and the growing population in need of theses medicines pose critical public health questions over the long-term financial sustainability of continued treatment scale-up. In response to this, research interest has shifted beyond survival and viral suppression to optimising treatment safety and health-related quality of life with focus on regimens that are easier to take, offer less risk of toxicity and are more affordable, while remaining highly effective. Dual therapy, using two anti HIV medicines instead of three with at least one anchor drug, is one of these approaches for initial and continued treatment.

What are D3’s objectives?

What are D3s objectives?

The D3 trial will assess whether the combination of DTG/3TC is just as effective as the standard of care in terms of virological suppression in children and adolescents. The trial will also compare the toxicity, adherence, tolerability, acceptability and quality of life in participants of this combination versus that of the standard of care.

D3 is funded by Viiv Healthcare and sponsored by Penta in close collaboration with the MRC CTU leading the operations activities and with active participation of PHPT CTU (Thailand)

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