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PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

This study has been completed.
Information provided by:
Gilead Sciences Identifier:
First received: March 21, 2008
Last updated: April 7, 2008
Last verified: April 2008
Open-label pharmacokinetic drug interaction study.

Condition Intervention Phase
Hepatitis B
Drug: Adefovir Dipivoxil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome 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 ]

Secondary Outcome 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 ]

Enrollment: 16
Study Start Date: February 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Arm 1
Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
Drug: Adefovir Dipivoxil
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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).
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Please refer to this study by its identifier: NCT00644761

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
California Pacific Medical Center
San Francisco, California, United States, 94115
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, New York
NYU Medical Center
New York, New York, United States, 10016
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Mayo Clinic
Rochester, New York, United States, 55905
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Gilead Sciences
  More Information

Responsible Party: Elsa Mondou, MD, Gilead Sciences Identifier: NCT00644761     History of Changes
Other Study ID Numbers: GS-02-531
Study First Received: March 21, 2008
Last Updated: April 7, 2008

Keywords provided by Gilead Sciences:
Hepatitis B
Post-Liver Transplantation
Adefovir Dipivoxil

Additional relevant MeSH terms:
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Adefovir dipivoxil
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents processed this record on May 25, 2017