Preemptive therapy vs valacyclovir prophylaxis for cytomegalovirus (CMV) disease after renal transplantation
A randomised study comparing universal valacyclovir prophylaxis with quantitative polymerase chain reaction (PCR) based preemptive therapy for cytomegalovirus (CMV) disease in renal transplant recipients.
Tomas Reischig, M.D., Ph.D.
60 participants
Oct 22, 2003
Interventional
Conditions
Summary
The aim of the study is to compare the efficacy, safety and cost of preemptive therapy with vaganciclovir (based on quantitative PCR monitoring) versus universal 3-month prophylaxis with valacyclovir (control group, current standard in our transplant centre).
Eligibility
Inclusion Criteria1
- adult (>18 years) renal transplant recipient, donor (D) and recipient (R) pretransplant CMV serological status: D+/R-, D+/R+, D-/R+, deceased (including non-heart-beating) or living donor, informed consent
Exclusion Criteria1
- unknown or D-/R- CMV serostatus pretransplant, allergy to acyclovir, valacyclovir, ganciclovir, and/or valganciclovir, active viral infection at the time of transplantation (including active hepatitis B infection), therapy with systemic antiviral agents <2 weeks prior to transplantation, white blood cell (WBC) count <3.5 x 10exp9/L, platelet count <100 x 10exp9/L, inability to sign informed consent, concomitant inclusion to another clinical trial
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Interventions
Preemptive therapy in the case of significant positivity of PCR for CMV deoxyribonucleic acid (DNA) (>2000 copies/ml) - oral valganciclovir (Valcyte, Hoffman-La Roche, Germany) 900mg twice per day until clearance of CMV viremia (negative result of PCR for CMV DNA) or for a minimum of 14 days commenced during first year post-transplant.
Locations(1)
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ACTRN12610000015044