The 2VAL Study: A trial comparing the effect of valacyclovir and valganciclovir prophylaxis against cytomegalovirus (CMV) infection after renal transplantation
Randomized trial comparing valacyclovir versus valganciclovir prophylaxis of cytomegalovirus infection in renal transplant recipients
Tomas Reischig, M.D., Ph.D.
114 participants
Nov 17, 2007
Interventional
Conditions
Summary
There are two major hypothesis to test: 1) Valacyclovir prophylaxis for cytomegalovirus infection is not inferior than valganciclovir prophylaxis in the prevention of active cytomegalovirus infection and disease. 2) Valacyclovir is superior to valganciclovir in the prevention of indirect effects of cytomegalovirus: acute renal allograft rejection in short term follow up, and renal function and chronic interstitial fibrosis and tubular atrophy (IF/TA) in long-term follow up.
Eligibility
Inclusion Criteria1
- Recipients of transplant from deceased or living donor, known donor (D) and recipient (R) CMV serology before transplantation of D+/R- or D+/R+ or D-/R+, provided informed consent
Exclusion Criteria1
- Unknown or D-/R- CMV serology prior to transplantation, systemic antiviral drug intake within 2 weeks before transplantation except for hepatitis B therapy (lamivudine, adefovir, entecavir), active viral infection at the time of transplantation (except for hepatitis B or C), significant leukopenia or thrombocytopenia, participation in another clinical trial, known allergy to (val)acyclovir or (val)ganciclovir, inability to provide informed concent
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Interventions
Oral valacyclovir (VALTREX, Glaxo Wellcome) 8g/day for 3 months after transplantation started within 1 week post transplant
Locations(1)
View Full Details on ANZCTR
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ACTRN12610000016033