A SEQUENTIAL REGIMEN WITH PEGYLATED-INTERFERON -2A PLUS TENOFOVIR FOR CHRONIC

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This prospective study was designed to determine the safety, tolerability, and activity of a sequential regimen with pegylated-interferon (Pegasys) and tenofovir DF (TNV) plus lamivudine (3TC) as part of highly active antiretroviral therapy (HAART) for hepatitis B in HIV infected subjects. A total of 45 subjects (5 at the IU site) will be enrolled and randomized to one of three treatment arms. Subjects on all treatment arms will receive treatment with Pegasys for 24 weeks: Pegasys 180 mcg injected subcutaneously once weekly, or Pegasys plus tenofovir for 24 weeks, or Pegasys plus tenofovir added at week 18. At week 24, the Pegasys will be stopped, but the tenofovir treatment in addition to lamivudine and HAART will continue for 24 more weeks. Subjects will be evaluated with abdominal ultrasounds, laboratory tests, and a liver biopsy. Up to 12 study visits will be required over a forty-eight week study period for each subject.