Status:
COMPLETED
Tenofovir in HIV/HBV Coinfection
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
The University of New South Wales
Gilead Sciences
Conditions:
HIV Infection
Hepatitis B Coinfection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)
Detailed Description
A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral ki...
Eligibility Criteria
Inclusion
- Written informed consent
- Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
- Age 18 - 70 years
- HBV DNA \> 105 copies/ml
- HBsAg positive \>6 months or HBsAg positive and anti HB core IgM negative
- Creatinine \<= 2.0mg/dl (\<= 0.2 mmol/L)
- Platelet count \>= 50,000/mm
- HIV-1 antiretroviral therapy naïve
- No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed
Exclusion
- HCV-RNA positive or Anti-HAV IgM positive
- Acute hepatitis (serum ALT \> 1000 U/L)
- Active opportunistic infection
- Other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
- Concurrent malignancy requiring cytotoxic chemotherapy
- Decompensated or Child's C cirrhosis
- Alfa-fetoprotein (AFP) \> 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
- Pregnancy or lactation
- Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00192595
Start Date
January 1 2004
End Date
January 1 2007
Last Update
April 1 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
2
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
3
Thai Red Cross AIDS Research Centre
Bangkok, Thailand