HIV AGING AND COGNITION: A SYNERGISM - REPOSITORY STUDY

HIV 衰老与认知：协同作用 - 数据库研究

• 批准号: 8174452
• 负责人: KARL GOODKIN
• 金额: $ 8.78万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174452
• 关键词: Acquired Immunodeficiency Syndrome; Address; Age; Aging; Attention; Biological Assay; Blood; Blood specimen; Cerebrospinal Fluid; Cervical; Clinical; Code; Cognition; Cognitive; Computer Retrieval of Information on Scientific Projects Database; Contracts; Data; Development; Disease; Emigrant; Enrollment; Excision; Frequencies; Funding; Future; Genetic Markers; Grant; HIV; Highly Active Antiretroviral Therapy; Histocompatibility Testing; Immune; Impaired cognition; Individual; Institution; Investigation; Laboratories; Links List; Measures; Memory; National Institute of Mental Health; Nature; Neurocognitive; Pap smear; Participant; Peptide T; Peripheral Blood Mononuclear Cell; Persons; Plasma; Protocols documentation; Recruitment Activity; Research; Research Ethics Committees; Research Personnel; Research Project Grants; Resources; Sampling; Sampling Studies; Severities; Site; Source; Specimen; Staging; T-Cell Receptor; Time; Tissues; Tube; United States National Institutes of Health; Universities; Urine; Viral Load result; Virus Diseases; Visit; Work; age group; base; follow-up; functional status; novel; parental monitoring; peripheral blood; programs; reconstitution; repository; research study; synergism

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. The purpose of this research study is to compare the frequency, nature and severity of cognitive impairment (e.g., memory; attention); neurocognitive disorders; and functional status between younger (18-39 years) and older (50 years and older) individuals infected with HIV (Human Immunodeficiency Virus) in its symptomatic stages. The relationship of aging to plasma viral load and to immunological decrements over time will also be assessed. This study will establish a repository at CSMC for plasma and peripheral blood mononuclear cells (PBMCs), urine specimen, and cervical tissue for the "HIV and Aging" (Pro00012492) IRB approved study. The repository's focus will be to provide information on the frequency, nature and severity of problems in cognition (e.g., memory; attention) that occur in younger (18-39 years) [n=20] and older (50 years and older) [n=20] individuals infected with HIV. HIV negative individuals in the same younger [n=20] and older [n=20] age groups are asked to participate as controls. This repository will be established for the investigation of the relationship between cognition and clinical laboratory progression measures in the blood that are markers of HIV clinical progression. Information may be obtained that will serve as predictors for the subsequent development of cognitive problems in older vs. younger HIV+ persons. These predictors will also potentially include genetic markers. Blood samples will be drawn for a total of 120ml over the course of the study. 40ml will be collected at the baseline visit, and 40 ml will be collected at the two annual follow-up visits. Part of the specimens will sent to UCLA for later virologic assays to be conducted en masse. It will not be necessary to share identifiable PHI with investigators at UCLA. No specimens will be sent from UCLA to CSMC. UCLA investigators will not interact with subjects, either here or at UCLA, for the purposes of this research. Also, CSMC investigators will not interact with subjects at UCLA for the purposes of this research. The samples to be sent to UCLA are 2 10 ml. tubes of peripheral blood from aging study participants in which PBMCs will be isolated. The remaining 20 ml are for long-term storage for other future, yet-to-be-planned assays. The urine and cervical tissue (from the Pap smear) specimens will be collected under the Aging Study and will be included as remnant samples. Cerebrospinal fluid was collected under previously approved protocols for this repository and will be maintained in this repository. The remainder of the samples (serum, plasma, and CSF) from the NIMH repository for one of these prior protocols (the NIMH's Peptide T Trial) will be transferred to CSMC. This is a continuation of a research project initiated at the University of Miami, where 279 subjects were previously enrolled. 80 more subjects will be recruited at CSMC. Data collected from participants at the University of Miami will be incorporated as part of the research conducted at CSMC. A plasma and peripheral blood mononuclear cell (PBMC) repository was included from the inception of the NIH-funded research project and will be necessary to continue in order for the renewal from which it is hoped that novel studies may be performed to further generate data beyond the scope of the actual proposal itself on the basis of the funding for this research. PBMCs will be stored to provide future resources to explore other important measures. This repository will be maintained at CSMC only. There are no collaborating repository sites, and the University of Miami will no longer be involved as a site of the study. Study investigators to be included from this point onward will be from CSMC and UCLA (working on sub-contract to CSMC). The University of Miami has been so notified, and the study was closed with the University of Miami IRB upon the PI¿s departure from that institution. This repository will also contain de-identified samples that can be used to address questions related to the presence/absence of HIV from the University of Miami collected by Dr. Goodkin during three previous NIH-funded research studies. The entire repository will be maintained and monitored by the parent HIV & Aging Study Investigators of protocol 12492. (AME 7646) REGARDING NIMH SAMPLES WHICH WILL BE TRANSFERRED TO CSMC : The Deputy Director of the NIMH AIDS Program Office, Dr. Dianne Rausch, requested that the PI maintain the remainder of the repository from that trial for the NIMH and that the samples be transferred from the NIMH's repository site to CSMC. The proposed CSMC repository addition from NIMH consists solely of plasma, serum, and CSF samples (which are the same tissue types originally included in the current repository from that trial). - No personal identifiers will be associated with the samples to be transferred. - The information that will be associated with the samples being transferred from the NIMH's repository will be coded. - CSMC investigators will not have access to the linking list associated with information from other study sites. -The researchers at this site have access solely to the linking list for those participants that were recruited at the PI's prior institution. [The study was completed before the PI moved to CSMC in 2007]. The specific aims for the HIV & Aging study samples are: Plasma, peripheral blood mononuclear cells, and remnant samples of urine and cervicel smears will be added to the previously stored samples to provide future resources to explore other measures related to HIV and aging, such as T cell receptor excision circles (TRECs), which may explain an interaction between thymic involution with older age and decreased thymic emigrants as well as long-term immune reconstitution with highly active antiretroviral therapy (known as "HAART"). It is anticipated that novel studies may be performed to further generate data beyond the scope of the actual proposal itself on the basis of this repository. In addition, the existing plasma, PBMCs, urine, CSF and cervical smears from the three prior NIMH HIV/AIDS studies of the PI will continue to be retained for questions related to the presence/absence and impact of HIV infection. The remainder of the samples (serum, plasma, and CSF) from the NIMH repository for one of these NIMH HIV/AIDS prior protocols (the NIMH's Peptide T Trial) will be transferred to CSMC.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 对于中心来说，它不一定是研究者的机构。 本研究的目的是比较年轻（18-39 岁）和年长（50 岁及以上）感染者的认知障碍（例如记忆力、注意力）和功能状态的频率、性质和严重程度。还将评估处于症状阶段的艾滋病毒（人类免疫缺陷病毒）的年龄与血浆病毒载量和免疫功能随时间下降的关系。 本研究将在 CSMC 建立血浆和外周血单核细胞 (PBMC)、尿液样本和宫颈组织的存储库，用于 IRB 批准的“HIV 与衰老”(Pro00012492) 研究。该存储库的重点是提供有关频率的信息。年轻人（18-39 岁）[n=20] 和老年人（50 岁及以上）中发生的认知问题（例如记忆力、注意力）的性质和严重性[n=20] 感染 HIV 的个体被要求作为对照组参与同一年轻 [n=20] 和老年 [n=20] 年龄组的个体。 该存储库将用于调查血液中的认知与临床实验室进展测量之间的关系，这些血液中的临床实验室进展测量是艾滋病毒临床进展的标志，可以获得的信息将作为老年人与年轻人认知问题后续发展的预测因子。 HIV阳性者。这些预测因素也可能包括遗传标记。 研究过程中将抽取总共 120 毫升的血液样本，其中 40 毫升将在基线访视时收集，并在每年两次随访时收集 40 毫升，部分样本将送往加州大学洛杉矶分校进行。无需与 UCLA 的研究人员共享可识别的 PHI。 UCLA 的研究人员不会与受试者进行互动。加州大学洛杉矶分校，出于本研究的目的，CSMC 研究人员也不会出于本研究的目的与加州大学洛杉矶分校的受试者进行互动。 送到加州大学洛杉矶分校的样本是来自衰老研究参与者的 2 管 10 毫升外周血，其中的 PBMC 将被分离出来，用于长期储存以用于其他未来尚未计划的检测。 尿液和宫颈组织（来自子宫颈抹片检查）样本将在衰老研究中收集，并将作为剩余样本包含在内。 脑脊液是根据之前批准的该储存库的方案收集的，并将保存在该储存库中，来自 NIMH 储存库的这些先前方案之一（NIMH 的肽 T 试验）的剩余样本（血清、血浆和脑脊液）将保存在该储存库中。转移至华润上华。 这是迈阿密大学发起的一项研究项目的延续，之前已招募了 279 名受试者，CSMC 将招募另外 80 名受试者，从迈阿密大学的参与者收集的数据将纳入迈阿密大学进行的研究的一部分。 CSMC。从 NIH 资助的研究项目开始就包括了血浆和外周血单核细胞 (PBMC) 储存库，并且有必要继续进行更新，希望可以从中进行新的研究以进一步生成。超出本研究资助范围的实际提案本身的数据将被存储，以便为探索其他重要措施提供未来资源。 该存储库将仅在 CSMC 维护。没有合作存储库站点，迈阿密大学将不再作为研究站点参与其中，从此时起，研究人员将来自 CSMC 和加州大学洛杉矶分校（在职）。迈阿密大学已收到此通知，并根据 PI 与迈阿密大学 IRB 结束了该研究。离开该机构。 该存储库还将包含古德金博士在美国国立卫生研究院资助的前三项研究中收集的迈阿密大学的去识别化样本，可用于解决与是否存在艾滋病毒相关的问题。 整个存储库将由协议 12492 的父级 HIV 和衰老研究调查员进行维护和监控。 (AME 7646) 关于将转移至华润上华的镍氢电池样品： NIMH 艾滋病项目办公室副主任 Dianne Rausch 博士要求 PI 为 NIMH 保留该试验的剩余存储库，并将样本从 NIMH 的存储库站点转移到 CSMC。 NIMH 提议添加的 CSMC 存储库仅包含血浆、血清和脑脊液样本（与该试验当前存储库中最初包含的组织类型相同）。 - 待传输的样本不会与任何个人标识符相关联。 - 与从 NIMH 存储库传输的样本相关的信息将被编码。 - CSMC 研究者将无权访问与其他研究中心信息相关的链接列表。 - 本网站的研究人员只能访问在 PI 之前所在机构招募的参与者的链接列表 [该研究是在 2007 年 PI 转到 CSMC 之前完成的]。 HIV 与衰老研究样本的具体目标是： 血浆、外周血单核细胞、尿液和宫颈涂片的残余样本将被添加到之前存储的样本中，为未来探索与艾滋病毒和衰老相关的其他措施提供资源，例如T细胞受体切除圈（TREC），这可能解释了胸腺退化与年龄增长和胸腺迁移减少以及高活性抗逆转录病毒治疗（称为“HAART”）的长期免疫重建之间的相互作用。可以在该存储库的基础上进行新颖的研究，以进一步生成超出实际提案本身范围的数据。 此外，PI 先前三项 NIMH HIV/AIDS 研究中现有的血浆、PBMC、尿液、CSF 和宫颈涂片将继续保留，用于解答与 HIV 感染的存在/不存在及其影响相关的问题。 NIMH 储存库中用于 NIMH HIV/AIDS 先前方案之一（NIMH 的肽 T 试验）的剩余样本（血清、血浆和脑脊液）将被转移到 CSMC。