Efficacy and Safety of PegIFN +/- FTC / TDF to Treat Chronic Hepatitis B in HIV-Coinfected Patients
Status:
Terminated
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
The efficacy of pegylated interferons in the treatment of chronic hepatitis B has shown
superior results to standard of care in patients only infected with hepatitis B. The efficacy
of pegylated interferon for the treatment of chronic hepatitis B in HIV-coinfected patients
is not known at present.
The purpose of this study is to evaluate the efficacy of pegylated interferon in the
treatment of chronic hepatitis B in HIV-infected individuals.
Apart from evaluating the efficacy of pegylated interferon therapy in this setting as such,
i.e. in patients without present or future need of highly active antiretroviral therapy
(HAART) for HIV-infection, there is a second purpose of this study, to investigate whether
combination treatment of HBV-infection may be superior to pegylated interferon therapy alone.
Therefore patients without need of HAART are offered pegylated interferon alfa-2a over 48
weeks. Patients who require HAART are offered emtricitabine / tenofovir DF containing HAART
over 72 weeks PLUS pegylated interferon alfa-2a over 48 weeks vs. emtricitabine / tenofovir
DF containing HAART over 72 weeks WITHOUT pegylated interferon-alfa-2a.