A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
Summary
This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir. Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it. After treatment, each participant will be followed up for up to 12 weeks. Participants will visit their study clinic up to 18 times during the study.
Timeline
- Start
- 2017-04-14
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
Outcome
Missed primary endpoint
paper primary endpoint of noninferiority of maribavir was not met PMID 38036487 ↗
release “AURORA trial provided evidence of maribavir’s clinically meaningful and durable effect in cytomegalovirus infection in hematopoietic stem cell transplant patients despite missing the primary endpoint” takeda.com ↗
Publications
- Chou S, Winston DJ, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Gu J, Pocock G, Papanicolaou GA. Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection. J Infect Dis. 2025 Mar 17;231(3):e470-e477. doi: 10.1093/infdis/jiae469.
- Papanicolaou GA, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Fournier M, Murray RA, Wu J, Winston DJ; AURORA Trial Investigators. Treatment for First Cytomegalovirus Infection Post-Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir. Clin Infect Dis. 2024 Mar 20;78(3):562-572. doi: 10.1093/cid/ciad709.
- Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maribavir | Small molecule | 400 mg | Oral |
| Comparator | Valganciclovir | Small molecule | 450 mg | Oral |
| Comparator | Valganciclovir | Small molecule | 900 mg | Oral |