Status:
TERMINATED
An Assessment of Voriconazole Pharmacokinetics and Pharmacogenetics in Liver Transplant Recipients - Pilot Study
Lead Sponsor:
University of Pittsburgh
Conditions:
Liver Transplant
Fungal Infection
Eligibility:
All Genders
18+ years
Brief Summary
A fixed-dosing regimen of voriconazole is routinely used as prophylaxis against aspergillosis in liver transplant patients admitted to the transplant intensive care unit at UPMC. We hypothesize that u...
Detailed Description
All liver transplant patients receiving voriconazole prophylaxis are eligible to participate in this study. We propose a single-center, observational study in 15 liver transplant patients who are admi...
Eligibility Criteria
Inclusion
- Consecutive male or female liver transplant recipients, 18 years old, who are initiated on the voriconazole prophylactic regimen by their transplant physician as part of their standard care, will be eligible for inclusion in the study.
Exclusion
- Transplant recipients receiving voriconazole to treat an active fungal infection will be excluded. Transplant recipients that are concurrently receiving medications that are documented to affect voriconazole pharmacokinetics will be excluded. The agents included, but may not be limited to the following; carbamazepine, phenytoin, omeprazole, rifabutin, rifampin, ketoconazole, itraconazole, fluconazole, St. John's wort extract. Those who require therapy with protease inhibitors for human immunodeficiency virus (HIV) infection may be included in the study.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00371605
Start Date
December 1 2006
End Date
April 1 2007
Last Update
December 17 2007
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213