Tenofovir in HIV/HBV Coinfection (TICO)
HIV Infection, Hepatitis B Coinfection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring Hepatitis B, HIV, Treatment Naive
Eligibility Criteria
Inclusion Criteria: 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 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, 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
Sites / Locations
- St. Vincent's Hospital
- The Alfred Hospital
- Thai Red Cross AIDS Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm 1:
Arm 2
Amr 3
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)