This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).~Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)~Primary Objectives:~To compare the proportion of subjects with HBV DNA levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group~Secondary Objectives:~To evaluate the emergence of HBV resistance at 48 weeks~To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group~To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study~To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT>5x ULN)~To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks~To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA~Enrollment:~24 patients in Clinical trial A (of whom 16 enter substudy A1).~Clinical Trial A:~Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.~Inclusion Criteria:~Written informed consent~Documented HIV infection~Age 18 - 70 years~HBV DNA > 106 copies/ml~Randomization:~Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)~Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)
This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).~Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)