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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.
Once-daily dolutegravir/lamivudine fixed-dose formulations in children living with HIV: a pharmacokinetic and safety sub-study nested in the open-label, multicentre, randomised, non-inferiority D3/PENTA 21 trial.
Bevers LAH, Toledo G, Kisekka M, Kaudha E, Ahimbisibwe GM, Deprez I, Arumugan T, Variava E, Violari A, White I, Bbuye D, Nanduudu A, Mulwanyi E, Amuge P, Rutebarika DA, Kekitiinwa A, Kityo C, Musoke P, Archary M, Boles J, Thomason MJ, de Wildt SN, Giaquinto C, Colbers A, Burger DM, Buchanan AM, Chan MK, Jacobs TG, Turkova A; D3 TRIAL TEAM. Bevers LAH, et al. EBioMedicine. 2025 Oct;120:105929. doi: 10.1016/j.ebiom.2025.105929. Epub 2025 Sep 26. EBioMedicine. 2025. PMID: 41014973 Free PMC article. Clinical Trial.