Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Transplantation
Intervention: oral Valganciclovir vs oral Ganciclovir (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Oregon Health and Science University
Official(s) and/or principal investigator(s):
Ali J Olyaei, PharmD, Principal Investigator, Affiliation: Oregon Health and Science University
Ali J Olyaei, PharmD, Phone: 503-494-8132, Email: firstname.lastname@example.org
There is no significant difference in the incidence of CMV infection when using oral
valganciclovir or ganciclovir as prophylactic anti-viral therapy.
There exists a significant difference in the incidence of CMV infection when oral
valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis
to be tested should be defined.
Official title: Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir
Study design: Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Cross-Sectional, Time Perspective: Retrospective/Prospective
The objective for this retrospective clinical study is to describe the incidence of CMV
infection in orthoptic liver transplant recipients who receive oral valganciclovir or
ganciclovir as their CMV prophylactic anti-viral therapy.
CMV infection will be characterized as viremia, syndrome or disease by the abovementioned
methods for up to one year post-transplantation.
1. Patient and allograft survival based on donor/recipient CMV status
2. Incidence of graft rejection and loss associated with CMV infection
3. Time to hepatitis C virus (HCV) occurrence
4. Incidence of HSV, EBV and VZV reactivations
5. Severity of HCV occurrence based on biopsy reports based on the Knodell score
6. Safety and tolerability of oral valganciclovir and ganciclovir
Minimum age: 18 Years.
Maximum age: 80 Years.
- All liver transplants will be performed at Oregon Health & Science University (OHSU)
and the OHSU surgical and medical staff will treat patients.
- Portland Veterans Affairs Medical Center liver transplant recipients
- Patients deceased within thirty days of receiving liver allograft
- Patients with low risk of acquiring CMV infection: donor-negative and
- Patients undergoing re-transplantation
- Lost to follow-up (minimum follow-up is 1 year)
- History of CMV infection or disease
- Anti-CMV therapy within the past 30 d
- Severe, uncontrolled diarrhea or evidence of malabsorption.
Locations and Contacts
Ali J Olyaei, PharmD, Phone: 503-494-8132, Email: email@example.comAdditional Information
Starting date: August 2006
Last updated: August 16, 2006