Efficacy and safety of short-cycle, dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a multicentre, open-label, randomised, parallel, two-arm, non-inferiority trial

Summary Background Short-cycle antiretroviral therapy (ART), comprising 5 days on and 2 days off treatment, offers the potential for ART-free weekends, reduced toxicity, and improved quality of life for adolescents living with HIV, who typically have worse treatment outcomes than other age groups. We aimed to compare the efficacy and safety of short-cycle ART containing tenofovir disoproxil fumarate–lamivudine–dolutegravir with continuous ART in adolescents living with HIV in Africa. Methods We conducted an open-label, randomised, parallel, two-arm, non-inferiority trial (BREATHER Plus) in five clinical research centres across Kenya, South Africa, Uganda, and Zimbabwe. Adolescents (aged ≥12 years to