Clinical Research Directory

Inclusion Criteria (both arms): * ≥18 years old * Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant Inclusion Criteria (letermovir arm): * Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation * Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation Exclusion Criteria (both arms): * Multiorgan organ transplant * Received previous solid organ transplant or HSCT * Unable to take oral medications * Uncontrolled infections at the time of enrollment * Hemodynamically unstable or on mechanical ventilation at the time of enrollment * Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor * Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation * Received any anti-CMV drug treatment within 7 days prior to enrollment * Current user of recreational or illicit drugs or alcohol dependence * History of CMV disease prior to enrollment Exclusion Criteria (letermovir arm): * Previously participated in a letermovir study or any other study with CMV investigational agents * On dialysis or plasmapheresis at the time of enrollment * Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations * Child-Pugh Class C severe hepatic insufficiency * Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study * Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine