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Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial.
Domínguez-Rodríguez S, Lora D, Tagarro A, Moraleda C, Ballesteros Á, Madrid L, Manukyan L, Marcy O, Leroy V, Nardone A, Burger D, Bassat Q, Bates M, Moh R, Tam PI, Mvalo T, Magallhaes J, Buck WC, Sacarlal J, Mussime V, Chabala C, Mujuru HA, Rojo P; EMPIRICAL group. Domínguez-Rodríguez S, et al. Trials. 2025 Apr 30;26(1):144. doi: 10.1186/s13063-025-08841-7. Trials. 2025. PMID: 40307889 Free PMC article.
Brief Report: Suboptimal Lopinavir Exposure in Infants on Rifampicin Treatment Receiving Double-dosed or Semisuperboosted Lopinavir/Ritonavir: Time for a Change.
Jacobs TG, Mumbiro V, Chitsamatanga M, Namuziya N, Passanduca A, Domínguez-Rodríguez S, Tagarro A, Nathoo KJ, Nduna B, Ballesteros A, Madrid L, Mujuru HA, Chabala C, Buck WC, Rojo P, Burger DM, Moraleda C, Colbers A; EMPIRICAL Clinical Trial Group; EMPIRICAL Clinical Trial Group. Jacobs TG, et al. J Acquir Immune Defic Syndr. 2023 May 1;93(1):42-46. doi: 10.1097/QAI.0000000000003168. Epub 2023 Apr 1. J Acquir Immune Defic Syndr. 2023. PMID: 36724434 Free PMC article.
Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial.
Rojo P, Moraleda C, Tagarro A, Domínguez-Rodríguez S, Castillo LM, Tato LMP, López AS, Manukyan L, Marcy O, Leroy V, Nardone A, Burger D, Bassat Q, Bates M, Moh R, Iroh Tam PY, Mvalo T, Magallhaes J, Buck WC, Sacarlal J, Musiime V, Chabala C, Mujuru HA. Rojo P, et al. Trials. 2022 Jun 27;23(1):531. doi: 10.1186/s13063-022-06203-1. Trials. 2022. PMID: 35761406 Free PMC article.