Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients

Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir

Null Hypothesis:

There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy.

Alternate Hypothesis:

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplantation
• Intervention / Treatment: Drug: oral Valganciclovir vs oral Ganciclovir

Detailed Description

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.

Endpoints:

Primary Endpoint

CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation.

Secondary Endpoints

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

• Study Type: Observational
• Enrollment: 200

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All liver transplants will be performed at Oregon Health & Science University (OHSU) and the OHSU surgical and medical staff will treat patients.

Exclusion Criteria:

• 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 recipient-negative (D-/R-)
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Defined Population
• Time Perspectives: Other

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Ali J Olyaei, PharmD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Study Completion: January 1, 2007

Study Registration Dates

• First Submitted: August 11, 2006
• First Submitted That Met QC Criteria: August 11, 2006
• First Posted (Estimate): August 15, 2006

Study Record Updates

• Last Update Posted (Estimate): August 17, 2006
• Last Update Submitted That Met QC Criteria: August 16, 2006
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Keywords: Valganciclovir, Oral Ganciclovir, Liver transplant
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Valganciclovir; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: VAL109