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

聚乙二醇化干扰素 -2A 加替诺福韦治疗慢性病的序贯疗法

• 批准号: 7379085
• 负责人: RAY W JOHNSON
• 金额: $ 0.07万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379085
• 关键词: SEQUENTIAL; REGIMEN; PEGYLATED; INTERFERON; 2A

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，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) 序贯治疗方案作为高效抗逆转录病毒治疗 (HAART) 的一部分，治疗 HIV 感染者乙型肝炎的安全性、耐受性和活性。总共 45 名受试者（其中 5 名在 IU 中心）将被纳入并随机分配到三个治疗组之一。所有治疗组的受试者将接受 Pegasys 治疗 24 周：每周皮下注射一次 Pegasys 180 mcg，或 Pegasys 加替诺福韦 24 周，或 Pegasys 加替诺福韦在第 18 周添加。在第 24 周，Pegasys 将停止，但除拉米夫定和 HAART 之外的替诺福韦治疗将继续持续 24 周。受试者将通过腹部超声、实验室测试和肝脏活检进行评估。每个科目在 48 周的研究期内最多需要 12 次研究访问。