Official Title: “A Multi-Center Phase 2, Open-Label Study to Evaluate the Pharmacokinetics of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil 10 mg to Patients Post-Liver Transplantation”

Open-label pharmacokinetic drug interaction study.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: May 2005

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.

Intervention(s) in this Clinical Trial

• Drug: Adefovir Dipivoxil
  • Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine

Arms, Groups and Cohorts in this Clinical Trial

• Other: Treatment Arm 1
  • Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days

Primary Measures

• To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
  • Time Frame: 21 days
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: 21 days
    Safety Issue?: No

Inclusion Criteria:

• 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Gilead Sciences

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644761

Study ID Number: GS-02-531

ClinicalTrials.gov Identifier: NCT00644761

Health Authority: United States: Food and Drug Administration

Study Results