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

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。背景：本研究的目的是发现长期使用聚乙二醇干扰素（PEG-IFN）治疗是否能减缓丙型肝炎病毒感染者肝损害的发生率。具体目的和程序（摘要）：第一部分：如果参与者从未接受过HCV治疗，将给予PEG-IFN和利巴韦林12周；他们过去曾接受PEG-IFN、IFN或IFN和利巴韦林治疗长达一年，但已经停止治疗12周；或者他们已经用某种干扰素治疗了至少12周，但仍然有丙型肝炎病毒。治疗12周后，所有参与者都将进行肝脏活检。第2部分：对12周治疗没有反应迹象的参与者将被随机分配单独接受PEG-IFN 72周或继续进行72周的研究治疗。第3部分：对12周治疗有反应迹象的参与者将继续接受PEG-IFN和利巴韦林72周，然后再进行24周的治疗。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.