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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项前瞻性研究旨在确定聚乙二醇干扰素（Pegasys）和替诺福韦DF （TNV）加拉米夫定（3TC）序贯方案的安全性、耐受性和活性，作为HIV感染者乙型肝炎高活性抗逆转录病毒治疗（HAART）的一部分。共有45名受试者（5名在IU现场）将被纳入，并随机分配到三个治疗组中的一个。所有治疗组的受试者将接受为期24周的Pegasys治疗：每周一次皮下注射Pegasys 180 mcg，或Pegasys加替诺福韦24周，或Pegasys加替诺福韦第18周。在第24周，Pegasys将停止，但替诺福韦治疗加上拉米夫定和HAART将继续24周。受试者将通过腹部超声、实验室检查和肝脏活检进行评估。在48周的研究期内，每个受试者最多需要进行12次研究访问。

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.