Status:
UNKNOWN
A Surveillance Program for the Detection of Hepatitis B Virus (HBV) Resistance to Tenofovir in HIV-HBV co-Infected Patients
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Infections
Hepatitis B Virus
Eligibility:
All Genders
18+ years
Brief Summary
Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently observed due to shared routes of transmission, with reported figures indicating 6-9% of HIV-infected individuals i...
Detailed Description
Tenofovir disoproxil fumarate (TDF) is a nucleotide analogue that can inhibit both HIV and HBV DNA polymerases, and is active against wild-type HBV and HBV strains that contain lamivudine-associated p...
Eligibility Criteria
Inclusion
- 18 years of age and older
- HIV positive
- 2 positive Hepatitis B surface antigen results at least 6 months apart
- currently receiving (or about to commence) tenofovir therapy
Exclusion
- unable to provide informed consent
- lack of a serum sample prior to commencing tenofovir
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00660361
Start Date
April 1 2008
End Date
September 1 2010
Last Update
April 17 2008
Active Locations (1)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004