Core B: Clinical and Anatomic Pathology Core

核心 B：临床和解剖病理学核心

• 批准号: 10223141
• 负责人: SUSAN JANET LITTLE
• 金额: $ 40.57万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10223141
• 关键词: AIDS clinical trial group; Address; Adult; Altruism; Anatomy; Autopsy; Bar Codes; Biological; Biological Markers; Blood; Cardiovascular Diseases; Clinical; Clinical Data; Collection; Complex; Development; Early treatment; Enrollment; Ensure; Equipment and supply inventories; Ethics; Gifts; Goals; HIV; Human; Individual; Infection; Infrastructure; Interruption; Investigation; Label; Life; Malignant Neoplasms; Measures; Organ; Participant; Pathology; Pathway interactions; Pattern; Performance; Peripheral Blood Mononuclear Cell; Persons; Plasma; Primary Infection; Procedures; Program Efficiency; Program Research Project Grants; Research Project Grants; Resources; Sampling; Services; Shipping; Solid; Specimen; Specimen Handling; Terminal Disease; Terminally Ill; Tissue Sample; Tissues; Transportation; Viremia; Virus; Work; antiretroviral therapy; biobank; cohort; improved; insight; programs; prospective; recruit; sample collection; treatment research; viral rebound; volunteer

Core B. Clinical and Anatomical Pathology Core: Abstract The Clinical and Anatomic Pathology Core (CAP, Core B) will provide critical infrastructure support to the proposed `Revealing Reservoirs during Rebound' (R3) program. While antiretroviral treatment (ART) can effectively suppress HIV replication and prolong life of infected individuals, the virus persists in a latent state, only to re-emerge when ART is stopped. HIV-infected persons who interrupt their ART, offer a valuable opportunity to better understand how HIV persists throughout the body. The CAP Core is one of three Cores providing support services to R3 scientific Research Projects (RPs) to improve program efficiency. Overall, the CAP Core will oversee the collection, transportation, processing, and storage of biological samples from both existing cohorts and prospectively identified cohorts. Specifically, the Early Treatment RP will provide biological samples from existing and ongoing cohorts of HIV-infected individuals who initiated ART early after infection (Zurich Primary Infection Cohort and AIDS Clinical Trials Group A5345), had fully suppressed viremia for at least 48 weeks, and who later stopped therapy. The Late Treatment RP will evaluate biological samples collected from a prospectively recruited cohort of altruistic HIV-infected individuals on ART who have a terminal illness (e.g. solid organ cancer, cardiovascular disease) and who will voluntarily stop their ART before they die and then donate their bodies to the program (the `Last Gift' cohort). All of these samples will be used to measure cellular and tissue reservoirs of HIV to best understand how HIV reservoirs persist during ART and after voluntary ART interruption. Biological samples collected from the Early Treatment RP (blood plasma and PBMC) and Late Treatment RP (blood and full body tissues) participants will constitute the R3 Biorepository, managed by the CAP Core. The CAP Core will also support all clinical activities related to the Last Gift cohort including study enrollment, management, specimen collection, and post-mortem autopsy to address viral rebound patterns across a wide variety of tissue samples and will ensure that procedures related to biological specimen collection are safe and ethical. Overall, the CAP Core will address the following Specific Aims: 1) Support the Early Treatment RP with specimen shipping, storage and management; 2) Support Late Treatment Research RP with management of the Last Gift cohort; 3) Support Late Treatment RP with specimen shipping, storage and management from Last Gift cohort; and 4) Support the R3 Biorepository. The CAP Core will work collaboratively with the program RP and Cores to support coordinated development of the R3 Biorepository and appropriate access to research specimens. Together, these activities will provide efficiency throughout the R3 program.

核心 B. 临床和解剖病理学核心：摘要 临床和解剖病理学核心（CAP，核心 B）将为 拟议的“反弹期间揭示储层”（R3）计划。虽然抗逆转录病毒治疗（ART）可以 有效抑制HIV复制并延长感染者的生命，病毒持续处于潜伏状态， 仅当 ART 停止时才重新出现。中断 ART 治疗的 HIV 感染者可以提供宝贵的帮助 有机会更好地了解艾滋病毒如何在体内持续存在。 CAP 核心是为 R3 科学研究项目 (RP) 提供支持服务的三个核心之一 提高程序效率。总体而言，CAP 核心将监督收集、运输、处理和 存储来自现有队列和前瞻性确定队列的生物样本。具体来说， 早期治疗 RP 将提供来自现有和正在进行的 HIV 感染者群体的生物样本 谁在感染后尽早开始抗逆转录病毒治疗（苏黎世初级感染队列和艾滋病临床试验组 A5345）， 完全抑制病毒血症至少 48 周，后来停止治疗。后期治疗 RP 将 评估从前瞻性招募的利他性 HIV 感染者队列中收集的生物样本 患有绝症（例如实体器官癌、心血管疾病）且自愿接受 ART 的人 在死前停止他们的 ART，然后将他们的遗体捐赠给该计划（“最后的礼物”队列）。所有这些 样本将用于测量 HIV 的细胞和组织储存库，以更好地了解 HIV 储存库如何 在 ART 期间和自愿 ART 中断后持续存在。从早期治疗中收集的生物样本 RP（血浆和 PBMC）和后期治疗 RP（血液和全身组织）参与者将构成 R3 生物样本库，由 CAP 核心管理。 CAP 核心还将支持与以下相关的所有临床活动 最后的礼物队列包括研究登记、管理、标本采集和尸检 解决各种组织样本中的病毒反弹模式，并将确保相关程序 生物标本采集是安全且合乎道德的。总体而言，CAP 核心将解决以下具体问题 目标：1) 通过标本运输、储存和管理支持早期治疗 RP； 2) 迟到的支持 治疗研究 RP 与最后一份礼物队列的管理； 3) 支持后期治疗RP与标本 Last Gift 队列的运输、存储和管理； 4) 支持 R3 生物样本库。 CAP 核心 将与 RP 和 Cores 项目合作，支持 R3 的协调发展 生物样本库和适当获取研究标本。这些活动共同将提高效率 整个 R3 计划。