Analysis of Stored Samples Collected Using Previously Expired Protocols

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Abstract

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 2016-2017.