PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
- Registration Number
- NCT00644761
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Open-label pharmacokinetic drug interaction study.
- Detailed Description
Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in Cohort 1, a decision was made on whether to enroll subjects in Cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was not enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 18-65 years of age
- Greater than or equal to 6 months post-liver transplantation
- Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months.
- Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm 1 Adefovir Dipivoxil Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
- Primary Outcome Measures
Name Time Method To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation 21 days
- Secondary Outcome Measures
Name Time Method To evaluate PK of ADV 10 mg once daily when co-administered with tacrolimus or cyclosporine in patients post-liver transplantation. To evaluate the safety of ADV 10 mg once daily, when co-administered with tacrolimus or cyclosporine for 14 days. 21 days
Trial Locations
- Locations (11)
University of Miami
🇺🇸Miami, Florida, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, New York, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
NYU Medical Center
🇺🇸New York, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States