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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本前瞻性研究旨在确定聚乙二醇干扰素（派罗欣）和替诺福韦DF（TNV）加拉米夫定（3 TC）序贯方案作为高效抗逆转录病毒治疗（HAART）的一部分治疗HIV感染者的B型肝炎的安全性、耐受性和活性。共45例受试者（5例在IU研究中心）将入组并随机分配至3个治疗组之一。所有治疗组的受试者将接受Pegasys治疗24周：Pegasys 180 mcg每周一次皮下注射，或Pegasys加替诺福韦治疗24周，或Pegasys加替诺福韦治疗18周。在第24周，Pegasys将停止，但除了拉米夫定和HAART之外，泰诺福韦治疗将继续24周。将通过腹部超声、实验室检查和肝活检对受试者进行评价。每例受试者在48周的研究期内需要进行最多12次研究访视。

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.