This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient. This study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.
This study will enroll solid organ transplant recipients who develop cytomegalovirus infection and disease who have been treated. At the time of finishing treatment, if the clinician feels that secondary prophylaxis is indicated, they will be enrolled to receive Letermovir 480 mg orally once a day for 60 days. CMV specific T cell assays will be obtained at the initiation of secondary prophylaxis and at the discontinuation of secondary prophylaxis. Patients will be followed for 4 months following discontinuation of secondary prophylaxis to see if they relapse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
25
Open label 480 mg given daily for 60 days
Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases
Boston, Massachusetts, United States
RECRUITINGRate of Relapse after prophylaxis
Proportion of patients with relapsing CMV disease up to 6 months after starting drug
Time frame: 6 months after starting intervention
Opportunistic infection
Rate of opportunistic infections or other infectious outcomes in the letermovir arm.
Time frame: 6 months after starting
Adverse events associated with taking letermovir
Tolerability and compliance of patients taking letermovir in terms of adverse events
Time frame: 6 months after starting
Neutropenia
Duration and nadir of neutropenia in the letermovir group
Time frame: 6 months after starting intervention
Rejection
Rate of rejection at 6 months after starting secondary prophylaxis in the letermovir arm.
Time frame: 6 months
T cell function
Proportion of patients who have demonstrated CMV specific T cell immunity at start of letermovir secondary prophylaxis will be compared to the proportion who have CMV specific T cell function at the discontinuation of prophylaxis
Time frame: 6 months after starting intervention
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