None listed
Conditions
Brief 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)
Interventions
Tenofovir, Lamivudine over 48 weeks
Sponsors
National Centre in HIV Epidemiology and Clincial Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed