Life-long ART presents new challenges of treatment fatigue and long-term toxicities, and the growing population in need of ART pose critical public health questions over the long-term financial sustainability of continued ART 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 antiretrovirals instead of three with at least one anchor drug, is one of these approaches for initial and maintenance therapy.
This open-label multicentre randomized non-inferiority trial, compares virological efficacy of two drug ART regimen, Dolutegravir (DTG) and lamivudine (3TC) (known as DTG/3TC), given in comparison with triple-drug standard-of-care (SOC) ART consisting of 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).
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.
Expected impact: To have DTG/3TC as a non-inferior ART option for children and adolescents living with HIV, to maintain viral suppression with minimal ART toxicity.
Recruitment rate: 99% (103 of 104)
Retention rate: 100%
