Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kirby Institute
With
The University of New South Wales
Gilead Sciences
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 kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
