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BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily ART in virologically suppressed adolescents living with HIV aged 12 to <20 years in sub-Saharan Africa.
Katongole F, Arumugam T, Jennings A, Mutata C, Ssebunya P, Wamboi C, Green A, Bwakura-Dangarembizi M, Kityo C, Siika A, Archary M, Jafta L, Namukwaya S, Seeley J, Mugerwa H, Walker S, Apoto N, Thomason MJ, Ford D, Pett SL, Kekitiinwa AR; BREATHER Plus trial team. Katongole F, et al. Contemp Clin Trials. 2025 Aug;155:107963. doi: 10.1016/j.cct.2025.107963. Epub 2025 May 29. Contemp Clin Trials. 2025. PMID: 40449658 Free PMC article.