CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")
Status:
Completed
Trial end date:
2018-06-22
Target enrollment:
Participant gender:
Summary
This is a trial of preemptive therapy vs. prophylaxis for prevention of Cytomegalovirus (CMV)
disease in R-D+ liver transplant patients. Subjects will be randomized within 10 days of
transplant to receive in an open label design, either antiviral prophylaxis with
valganciclovir, 900 mg orally once daily or preemptive therapy (weekly monitoring for CMV
viremia by plasma PCR) for 100 days post-randomization with initiation of oral valganciclovir
900mg orally twice daily at onset of CMV viremia and continued until plasma PCR is negative
on two consecutive weekly PCR tests). A minimum of 176 subjects will be enrolled in the
study. The study duration is 7 years. The primary objective of this study is to compare
prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease
in R-/D+ liver transplant recipients.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID) University of Pittsburgh