Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

2014-08-27 03:52:36 | BioPortfolio


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)


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


- 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


- Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)

- Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


HIV Infections


tenofovir, emtricitabine, zidovudine, efavirenz


Academic Medical Center




International Antiviral Therapy Evaluation Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:52:36-0400

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