Analysis of Stored Samples Collected Using Previously Expired Protocols

该方案将作为一种通用方案，在这些研究的原始方案关闭后，对存储的、编码的标本和从以其他方式完成的特定LIR临床试验获得的数据进行研究使用。当所有参与临床试验的受试者结束并且初步分析完成时，LIR将终止与NIAID机构审查委员会(IRB)的原始临床方案。在原始议定书终止备忘录中将说明是否有储存的标本和/或数据仍在使用中，根据这一一揽子议定书，将继续遵循这些标本和/或数据来处理人类主体保护问题。样本和/或数据获取的特定LIR协议的列表将保存在本协议的附录A中。NIAID IRB将被要求批准在附录A中增加新的研究。 该议定书的目的是在样品来源研究终止后，继续由NIAID IRB监督人类受试者的保护，同时向经批准的研究实验室和调查人员提供储存的标本和/或数据。继续的分析将在收集标本和数据的原始研究目标和同意范围内用于研究、探索性免疫学和传染病研究。主要研究目标的手稿完成也将包括在本研究方案或最初的研究方案中。 今年，下列议定书的数据和样本被转移到该项目： 04-I-0086慢性乙型和丙型肝炎及其并发症的临床、病毒学和免疫学因素评估，PI：Colleen Hadigan，MD。 13-I-0066评估多种抗-丙型肝炎病毒联合疗法在慢性丙型肝炎患者中的安全性和有效性的初步研究，PI：Henry Masur，MD。 14-CC-0065达拉他韦和阿昔洛韦在合并感染艾滋病毒-丙型肝炎病毒的受试者中的安全性、耐受性和有效性，无论是否使用BMS-791325，PI：Henry Masur，MD 出版物列在Zia CL009010-07项下。

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. This year 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 Publications accounted for under ZIA CL009010-07.