ACTG 5178: SUPPRESSIVE LONG-TERM ANTIVIRAL MANAGEMENT OF HEPATITIS C VIRUS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。背景：这项研究的目的是找出长期使用聚乙二醇化干扰素(聚乙二醇化干扰素)是否会减缓同样感染艾滋病毒的人中丙型肝炎引起的肝脏损害的速度。具体目标和程序(摘要)：第1部分：参与者如果从未接受过丙型肝炎病毒治疗，将接受为期12周的聚乙二醇干扰素和利巴韦林治疗；他们过去接受过聚乙二醇干扰素、干扰素或干扰素和利巴韦林治疗长达一年，但已停止治疗12周；或者接受某种形式的干扰素治疗至少12周，但仍感染丙型肝炎病毒。治疗12周后，所有参与者都将接受肝脏活检。第二部分：那些对12周的治疗没有反应的参与者将被随机分配到单独接受聚乙二醇化干扰素治疗72周，或者继续进行为期72周的非研究治疗。第三部分：对12周治疗有反应的参与者将继续接受72周的聚乙二醇化干扰素和利巴韦林治疗，然后继续进行研究，停止治疗24周。意义(摘要)：研究结果将提供给参与者。

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. Background: The purpose of this study is to find out whether long-term treatment with pegylated-interferon (PEG-IFN) slows the rate of liver damage caused by hepatitis C in people also infected with HIV. Specific Aims and Procedures (summary): Part 1: Participants will be given PEG-IFN and ribavirin for 12 weeks if they have never been treated for HCV; they have been treated in the past with PEG-IFN, IFN or IFN and ribavirin for up to one year, but have been off treatment for 12 weeks; or they have been treated with some form of IFN for at least 12 weeks and still have HCV. After 12 weeks of treatment, all participants will have a liver biopsy. Part 2: Participants who do not show signs of responding to the 12 weeks of treatment will be assigned by chance to either receive PEG-IFN alone for 72 weeks or to continue on study off treatment for 72 weeks. Part 3: Participants who sign signs of responding to the 12 weeks of treatment will continue to receive PEG-IFN and ribavirin for 72 weeks and then be followed on study for an additional 24 weeks off treatment. Significance (summary): Study findings will be available to participants.