Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
Maribavir for Refractory or Resistant Cytomegalovirus Infections in Hematopoietic-cell or Solid-organ Transplant Recipients: A Randomized, Dose-ranging, Double-blind, Phase 2 Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01611974 (A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus), which is not on this map. Cited by 97 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients
Who cites it
97 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Antiviral Agents for Preventing Cytomegalovirus Disease in Recipients of Hematopoietic Cell Transplantation.Viruses · 2024Pooled it
- Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients.The Cochrane database of systematic reviews · 2024Pooled it
- [Phase Ⅲ, multicenter, randomized, double-blinded, positive-controlled trial on the efficacy and safety of maribavir compared with valganciclovir in the treatment of post-transplant cytomegalovirus infection: Subgroup analysis of AURORA Trial in the Chinese population].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Trial
- Population Pharmacokinetics and Exposure-Response Relationships of Maribavir in Transplant Recipients With First Episode or Refractory Cytomegalovirus.CPT: pharmacometrics & systems pharmacology · 2025Trial
- Population pharmacokinetics and exposure-response relationships of maribavir in transplant recipients with cytomegalovirus infection.Journal of pharmacokinetics and pharmacodynamics · 2024Trial
- 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.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Drug Resistance Assessed in a Phase 3 Clinical Trial of Maribavir Therapy for Refractory or Resistant Cytomegalovirus Infection in Transplant Recipients.The Journal of infectious diseases · 2024Trial
- Maribavir Pharmacokinetics and Safety in Participants With Moderate Hepatic Impairment: A Phase 1, Open-Label, Single-Dose, Parallel Group Study.Journal of clinical pharmacology · 2023Trial
- Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Novel UL97 drug resistance mutations identified at baseline in a clinical trial of maribavir for resistant or refractory cytomegalovirus infection.Antiviral research · 2019Trial
- Human Cytomegalovirus Genetic Diversity, Clinical Relevance, and Emerging Insights.Reviews in medical virology · 2026Review
- Maribavir in lung transplant recipients with cytomegalovirus infection: real-life experience.Infection · 2026Article
- A novel inhibitor of human cytomegalovirus acts through a specific antiviral mechanism that involves the helicase-primase complex.Antimicrobial agents and chemotherapy · 2026Article
- Maribavir for cytomegalovirus retinitis: A case series and review of the literature.AJO international · 2026Article
- Quantitative analysis of [European journal of nuclear medicine and molecular imaging · 2026Article
- Cytomegalovirus Viral Load Continues to Predict Poor Outcomes in Adults and Children Despite Improved Hematopoietic Cell Transplantation Success.Open forum infectious diseases · 2025Article
- Article
- Real-world safety of maribavir: a retrospective study based on signal detection in the FDA adverse event reporting system.International journal of clinical pharmacy · 2025Article
- Review
- Efficacy of antimicrobials in preventing resistance in solid organ transplant recipients: A systematic review of clinical trials.World journal of transplantation · 2025Article
37 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundCytomegalovirus (CMV) infections that are refractory or resistant (RR) to available antivirals ([val]ganciclovir, foscarnet, cidofovir) are associated with higher mortality in transplant patients. Maribavir is active against RR CMV strains.
methodsHematopoietic-cell or solid-organ transplant recipients ≥12 years old with RR CMV infections and plasma CMV deoxyribonucleic acid (DNA) ≥1000 copies/mL were randomized (1:1:1) to twice-daily dose-blinded maribavir 400, 800, or 1200 mg for up to 24 weeks. The primary efficacy endpoint was the proportion of patients with confirmed undetectable plasma CMV DNA within 6 weeks of treatment. Safety analyses included the frequency and severity of treatment-emergent adverse events (TEAEs).
resultsFrom July 2012 to December 2014, 120 patients were randomized and treated (40 per dose group): 80/120 (67%) patients achieved undetectable CMV DNA within 6 weeks of treatment (95% confidence interval, 57-75%), with rates of 70%, 63%, and 68%, respectively, for maribavir 400, 800, and 1200 mg twice daily. Recurrent on-treatment CMV infections occurred in 25 patients; 13 developed mutations conferring maribavir resistance. Maribavir was discontinued due to adverse events in 41/120 (34%) patients, and 17/41 discontinued due to CMV infections. During the study, 32 (27%) patients died, 4 due to CMV disease. Dysgeusia was the most common TEAE (78/120; 65%) and led to maribavir discontinuation in 1 patient. Absolute neutrophil counts <1000/µL were noted in 12/106 (11%) evaluable patients, with rates similar across doses.
conclusionsMaribavir ≥400 mg twice daily was active against RR CMV infections in transplant recipients; no new safety signals were identified. CLINICAL TRIALS REGISTRATION: NCT01611974.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.