Virological and clinical anti-HBV efficacy of tenofovir in antiretroviral naive patients with HIV/HBV co-infection
A randomised mulitcentre trial of tenofovir (TDF) vs lamividine (LAM) vs TDF/LAM in antiretroviral naive subjects with HIV/HBV conifection over 48 weeks.
National Centre in HIV Epidemiology and Clincial Research
51 participants
Jan 26, 2004
Interventional
Conditions
Summary
A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naive 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 naive HBV mono-infected subjects (Substudy A1)
Eligibility
Inclusion Criteria1
- Written informed consent; Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA); 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 naive; No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed.
Exclusion Criteria1
- 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, haemachromatosis, 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.
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Interventions
Tenofovir, Lamivudine over 48 weeks
Locations(1)
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ACTRN12605000436673