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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

Summary

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)

Description

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)

Study Design

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

Conditions

HIV Infections

Intervention

tenofovir, emtricitabine, zidovudine, efavirenz

Location

Academic Medical Center
Amsterdam
NH
Netherlands
1105AZ

Status

Completed

Source

International Antiviral Therapy Evaluation Center

Results (where available)

View Results

Links

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

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