A5178: "PEG-IFN PLUS RBV FOR HCV CO-INFECTION"

A5178：“PEG-IFN 加 RBV 用于 HCV 合并感染”

• 批准号: 7381025
• 负责人: Jorge Santana
• 金额: $ 2.02万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7381025
• 关键词: A5178; PEG; IFN; PLUS; RBV

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. Design: This is a phase II, open-label, two-arm, long-term maintenance therapy study. This trial is designed to study whether long-term maintenance with pegylated-interferon alfa-2a (PEG-IFN) reduces the rate of liver fibrosis progression in subjects with HCV/HIV co-infection who have failed to achieve or maintain HCV loads below the limit of detection during treatment with PEG-IFN plus ribavirin. Both HCV treatment na¿ve and previously treated subjects will be enrolled. Duration: Subjects on Steps 1 and 2 will be followed for a maximum of 90 weeks. Subjects on Steps 1 and 3 will be followed for a maximum of 96 weeks. Sample Size: Depending on the proportion of na¿ve or previously treated vs. those rolled over from ongoing therapy, Step 1 may need to enroll up to 180 subjects. A total of 134 subjects will be randomized to Step 2: Arm B (67) and Arm (67). Population: Step 1: Two classes of HIV/HCV coinfected subjects will be admitted to Step 1: A. Subjects who are HCV treatment na¿ve or B. Subjects who failed to achieve HCV sustained virologic response to at least 12 weeks of any interferon-based therapy. Subjects must be ? 18 years of age, with reasonable likelihood for long-term follow-up and evaluation. Step 2: HIV/HCV coinfected subjects who have had exposure to and tolerated at least 12 weeks of PEG-IFN plus ribavirin and are currently: A. In Step 1 or B. On any other PEG-IFN plus ribavirin regimen. All subjects must have had at least 12 weeks of active therapy and demonstrate less than a 2-log drop in HCV RNA and have HCV RNA detectable in serum/plasma. Step 3: HCV/HIV coinfected subjects who achieved at least a 2 log-drop in HCV RNA or have undetectable HCV RNA after 12 weeks on Step 1, and who tolerated Step 1 therapy. Regimen: Step 1: all subjects will receive: Arm A consisting of: ? PEG-IFN 180 ¿g Q weekly for a minimum of 12 weeks (maximum of 18 weeks while awaiting the results required for randomization to Step 2) ? Ribavirin 1-1.2 g/day (weight based) for 12 weeks (maximum of 18 weeks while awaiting the results required for randomization to Step 2) Step 2: Subjects will be randomized to the following treatment arms: ? Arm B will be treated with PEG-IFN, given 180 ¿g once weekly for 72 weeks. ? Arm C is the observational control arm. Step 3: subjects registered to Step 3 will receive; Arm D, a continuation of Step 1 treatment (PEG-IFN 180 ¿g Q weekly plus ribavirin 1-1.2 g/day (weight based)) for a total of 72 weeks (12-18 weeks on Step 1 plus up to 60 weeks on Step 3). Subjects will then be followed for an additional 24 weeks.

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来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。设计：这是一项II期、开放标签、双臂、长期维持治疗研究。本试验旨在研究在接受聚乙二醇干扰素α-2a（PEG-IFN）联合利巴韦林治疗期间未能达到或维持HCV载量低于检测限的HCV/HIV合并感染受试者中，长期维持PEG-IFN治疗是否能降低肝纤维化进展率。将入组HCV初治受试者和既往接受过治疗的受试者。 持续时间：将对第1步和第2步的受试者进行最长90周的随访。 第1步和第3步的受试者将接受最长96周的随访。 样本量：根据初治或既往接受过治疗的受试者与从正在进行的治疗中转入的受试者的比例，第1步可能需要入组多达180例受试者。共134例受试者将随机分配至第2步：B组（67例）和组（67例）。 人群：第1步：两类HIV/HCV合并感染受试者将进入第1步：A。HCV初治或B的受试者。对任何基于干扰素的治疗至少12周未能达到HCV持续病毒学应答的受试者。主题必须是？18岁，有合理的可能性进行长期随访和评价。第2步：HIV/HCV合并感染受试者，已暴露于PEG-IFN+利巴韦林并耐受至少12周，目前：A.在步骤1或B中。任何其他PEG-IFN加利巴韦林方案。所有受试者必须接受至少12周的活性治疗，并证明HCV RNA下降小于2个对数，且血清/血浆中可检出HCV RNA。第三步：第1步治疗12周后HCV RNA下降至少2个对数或HCV RNA检测不到，且耐受第1步治疗的HCV/HIV合并感染受试者。 方案：第1步：所有受试者将接受：A组，包括：？PEG-IFN 180 μ g Q每周一次，至少持续12周（最长18周，同时等待随机化至步骤2所需的结果）？利巴韦林1-1.2 g/天（基于体重），持续12周（最长18周，同时等待随机分配至步骤2所需的结果）第2步：受试者将随机分配至以下治疗组：？B组将接受PEG-IFN治疗，180 μ g每周一次，持续72周。? C组为观察对照组。第3步：登记至第3步的受试者将接受; D组，继续第1步治疗（PEG-IFN 180 μ g Q每周一次加利巴韦林1-1.2 g/天（基于体重）），共72周（第1步12-18周，第3步最多60周）。然后将对受试者进行额外24周的随访。