Analysis of Stored Samples Collected Using Previously Expired Protocols

在这些研究的原始方案关闭后，本方案将作为研究使用储存的编码标本和从特定的已完成LIR临床试验中获得的数据的一揽子方案。 当所有受试者参与临床试验结束且主要分析完成时，LIR将与NIAID机构审查委员会（IRB）终止原始临床方案。 将在原始方案终止备忘录中说明是否有储存的标本和/或数据仍在使用中，将根据本一揽子方案继续跟踪人类受试者保护问题。 获取标本和/或数据的特定LIR方案列表将保存在本方案的附录A中。 将要求NIAID IRB批准在附录A中添加新研究。 本方案的目的是继续由NIAID IRB对人类受试者保护进行监督，同时在标本来源研究终止后，向批准的研究实验室和研究者提供储存的标本和/或数据。 继续分析将用于研究、探索性免疫学和感染性疾病研究，在原始研究目的和同意书范围内进行，样本和数据是根据这些研究目的和同意书采集的。 本方案或原始研究方案也将涵盖患者完成主要研究目的的情况。 2015-2017年，以下方案的数据和样本转移至本项目： 04-I-0086慢性B型和C型肝炎及其并发症发病机制的临床、病毒学和免疫学因素评价，PI：Colleen Hadigan，MD。 13-I-0066一项评价多种抗HCV联合治疗慢性感染丙型肝炎患者的安全性和有效性的初步研究，PI：亨利马苏尔，医学博士。 14-CC-0065达卡他韦和阿那匹韦联合或不联合BMS-791325治疗HIV-HCV合并感染受试者的安全性、耐受性和疗效，PI：亨利·马苏尔，医学博士 在2016-2020年期间，没有新的方案转移到该项目。 自上次报告以来，样品用于以下目的 04-I-0086慢性B型和C型肝炎及其并发症发病机制的临床、病毒学和免疫学因素评价，PI：Colleen Hadigan，MD。 抽取了10份血清样本 14-CC-0065达卡他韦和阿那匹韦联合或不联合BMS-791325治疗HIV-HCV合并感染受试者的安全性、耐受性和疗效，PI：亨利·马苏尔，医学博士 抽取了6份血清样本 样本可供进一步分析

This protocol will serve as a blanket protocol for the research use of stored, coded specimens and data obtained from specific otherwise completed LIR clinical trials after the original protocols for these studies have been closed. When all subject participation in a clinical trial ends and the primary analyses are complete, the LIR will terminate the original clinical protocol with the NIAID Institutional Review Board (IRB). It will be stated in the original protocols termination memo whether there are stored specimens and/or data remaining in use that will continue to be followed for human subject protection issues under this blanket protocol. A list of specific LIR protocols from which specimens and/or data are obtained will be maintained in Appendix A to this protocol. The NIAID IRB will be requested to approve the addition of new studies to Appendix A. The objective of this protocol is to continue to have human subjects protection oversight by the NIAID IRB while making stored specimens and/or data available to approved research laboratories and investigators after the study of specimen origin has been terminated. Continued analyses will be for the purpose of research, exploratory immunology, and infectious disease research within the original study objectives and consents under which the specimens and data were collected. Manuscript completion for the primary study objectives will also be covered under this or the original study protocol. In 2015-2017 data and samples from the following protocols were transferred to this project: 04-I-0086 Evaluation of Clinical, Virological, and Immunologic Factors that Contribute to the Pathogenesis of Chronic Hepatitis B and C and their Complications, PI: Colleen Hadigan, MD. 13-I-0066 A Pilot Study to Evaluate the Safety and Efficacy of Multiple Anti-HCV Combination Therapy in Chronically Infected Hepatitis C Patients, PI: Henry Masur, MD. 14-CC-0065 Safety, Tolerability, and Efficacy of Daclatasvir and Asunaprevir, with or without BMS-791325, in Subjects Coinfected With HIV-HCV, PI: Henry Masur, MD No new protocols were transferred to this project in 2016-2020. Samples were used for the following since the prior report 04-I-0086 Evaluation of Clinical, Virological, and Immunologic Factors that Contribute to the Pathogenesis of Chronic Hepatitis B and C and their Complications, PI: Colleen Hadigan, MD. 10 serum samples were pulled 14-CC-0065 Safety, Tolerability, and Efficacy of Daclatasvir and Asunaprevir, with or without BMS-791325, in Subjects Coinfected With HIV-HCV, PI: Henry Masur, MD 6 serum samples were pulled Samples are available for further analysis