Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
The rationale for this protocol is based on the need to assess if the current post stem cell
transplantation CMV prophylaxis strategies (e.g. high-dose acyclovir plus pre-emptive
treatment) can be improved by the use of valganciclovir. CMV is the most common viral
infection following stem cell transplantation, causing significant morbidity and mortality.
Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT
recipients including allograft dysfunction, acute and chronic graft versus host disease
(GVHD). Valganciclovir is shown to be more active than oral ganciclovir, and as good as
intravenous (i.v.) ganciclovir in treating newly diagnosed CMV retinitis. The use of
valganciclovir for CMV prophylaxis post stem cell transplantation was never tested in
controlled study. The investigators therefore suggest a prospective, randomized study to
evaluate the efficacy and safety of valganciclovir compared with acyclovir for prevention of
CMV disease in allogeneic stem cell transplantation recipients.