Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

Summary

This trial will evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

Timeline

Start

2020-03-01

Primary completion

2025-01-31

Completion

2025-01-31

Publications

• Moraleda C, Tagarro A, Dominguez-Rodriguez S, Musiime V, Mujuru H, Chabala C, Mvalo T, Iroh-Tam PY, Bramugy J, Madrid L, Sacarlal J, Passanduca A, Sidat M, Cassia U, Aanyu HT, Tagoola A, Mutata C, Nduna B, Chawinga C, Ghambi L, Bates M, Fernandez-Luis S, Seni A, Gafur M, Nalwanga D, Nansera D, Bwakura-Dangarembizi M, Namuziya N, Egbe FN, Tembo J, Ballesteros A, Moh R, Manukyan L, Lora D, Marcy O, Jacobs TG, Burger D, Bassat Q, Leroy V, Nardone A, Buck WC, Rojo P; Empirical Clinical Trial Group. Empirical treatment with valganciclovir in infants living with HIV and hospitalised with severe pneumonia in Africa: a multicentre, open-label, factorial, randomised, controlled, superiority trial. Lancet. 2026 Jul 17:S0140-6736(26)00754-3. doi: 10.1016/S0140-6736(26)00754-3. Online ahead of print.
• Jacobs TG, Mumbiro V, Tembo J, Egbe FN, Moraleda C, Beca LSDAB, Passanduca A, Kakooza L, Chitsamatanga M, Nduna B, Bramugy J, Tagarro A, Chhaganlal KD, Mutesi S, Mark NL, Bwakura-Dangarembizi M, Namuzizya N, Ballesteros A, Dominguez-Rodriguez S, Colbers A, Sacarlal J, Nalwanga D, Mujuru HA, Chabala C, Madrid L, Buck WC, Musiime V, Bates M, Rojo P, Burger DM; EMPIRICAL Clinical Trial Group. Pharmacokinetics and pharmacodynamics of valganciclovir in infants with severe HIV-associated pneumonia in Africa: a sub-study of the EMPIRICAL randomised controlled trial. EClinicalMedicine. 2026 Apr 13;94:103899. doi: 10.1016/j.eclinm.2026.103899. eCollection 2026 Apr.
• Dominguez-Rodriguez S, Lora D, Tagarro A, Moraleda C, Ballesteros A, 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. Statistical analysis plan for the "empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia" clinical trial. Trials. 2025 Apr 30;26(1):144. doi: 10.1186/s13063-025-08841-7.
• Jacobs TG, Mumbiro V, Chitsamatanga M, Namuziya N, Passanduca A, Dominguez-Rodriguez 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. Brief Report: Suboptimal Lopinavir Exposure in Infants on Rifampicin Treatment Receiving Double-dosed or Semisuperboosted Lopinavir/Ritonavir: Time for a Change. J Acquir Immune Defic Syndr. 2023 May 1;93(1):42-46. doi: 10.1097/QAI.0000000000003168. Epub 2023 Apr 1.
• Rojo P, Moraleda C, Tagarro A, Dominguez-Rodriguez S, Castillo LM, Tato LMP, Lopez 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. Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial. Trials. 2022 Jun 27;23(1):531. doi: 10.1186/s13063-022-06203-1.

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Indications