title: Maribavir and human cytomegalovirus-what happened in the clinical trials and why might the drug have failed?
abstract: We summarize the history of the clinical drug development of maribavir for its use as prophylaxis in stem-cell transplant recipients. We highlight key aspects in the design and interpretation of the results of the dose escalation phase II maribavir study that may have contributed to the negative findings on the phase III trials. We discuss key aspects of study design that should be considered in the study of new interventions needed to advance the prevention and treatment of CMV in transplant recipients.
authors.affiliation: Brigham & Women's Hospital, Harvard Medical School, United States.
authors.forename: Francisco M
authors.initials: FM
authors.lastname: Marty
authors.forename: Michael
authors.initials: M
authors.lastname: Boeckh
mesh_terms: D000818:Animals; D000998:Antiviral Agents / Q000494:pharmacology*; D001562:Benzimidazoles / Q000494:pharmacology*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000379:methods / Q000592:standards; D003587:Cytomegalovirus / Q000302:isolation & purification*; D003586:Cytomegalovirus Infections / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012263:Ribonucleosides / Q000494:pharmacology*; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D004004:Dichlororibofuranosylbenzimidazole / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D012263:Ribonucleosides; C400401:maribavir; D004004:Dichlororibofuranosylbenzimidazole