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.

该副本是使用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这是调查员的机构。 这项研究的目的是比较认知障碍的频率，性质和严重性（例如记忆；注意）；神经认知障碍；在症状阶段，年轻人（18-39岁）和年龄较大（50岁及以上）的年轻人（50岁及50岁）患者之间的功能状况。还将评估衰老与等离子体病毒载量与免疫学减少的关系。 这项研究将在CSMC上建立一个用于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“ HIV和衰老”​​（Pro00012492）IRB批准的研究。存储库的重点是提供有关在年轻人（18-39岁）[n = 20]和年龄较大（50岁及50岁及以上）[n = 20]患者感染HIV的认知问题（例如记忆；注意）中问题的频率，性质和严重程度（例如记忆；注意）。同一年轻人[n = 20]中的艾滋病毒负面个体，并要求年龄段的年龄段作为对照。 该存储库将建立用于研究血液中认知与临床实验室进展度量之间的关系，这是HIV临床进展的标志。可以获得信息，这些信息将作为随后在年龄较大的艾滋病毒+人与年龄较小的艾滋病毒+人中出现认知问题的预测因素。这些预测因子还可能包括遗传标记。 在整个研究过程中，将绘制血液样本的总计120毫升。将在基线访问时收集40毫升，将在两次年度随访中收集40毫升。这些标本的一部分将发送给UCLA，以便将后来的病毒式刺激汇总进行。与UCLA的调查人员共享可识别的PHI是没有必要的。不会将标本从UCLA发送到CSMC。就本研究而言，UCLA调查人员不会在这里或UCLA与受试者互动。此外，出于本研究的目的，CSMC调查人员不会与UCLA的受试者互动。 要发送到UCLA的样品为2 10毫升。衰老研究参与者的外周血管将分离出PBMC。其余的20毫升用于长期存储，用于其他未来，尚未计划的测定法。 尿液和宫颈组织（来自PAP涂片）标本将在衰老研究下收集，并将作为残留样品。 脑脊液是根据此存储库的先前批准的协议收集的，并将在此存储库中维持。 NIMH存储库中的其余样品（血清，等离子体和CSF）用于这些先前方案之一（NIMH的肽T试验）之一，将转移到CSMC。 这是在迈阿密大学启动的研究项目的延续，此前有279名受试者已入学。 CSMC将招募80名受试者。从迈阿密大学参与者收集的数据将作为CSMC进行的研究的一部分合并。从NIH资助的研究项目成立中包括血浆和外周血单核细胞（PBMC）存储库，必须继续进行续订，希望可以从中进行新的研究，以进一步生成该研究范围，以超越实际提案本身的范围。 PBMC将存储以提供未来的资源来探索其他重要措施。 该存储库仅在CSMC维护。没有合作的存储库站点，迈阿密大学将不再作为研究场所参与其中。从此开始的研究研究人员将来自CSMC和UCLA（从分包合同到CSMC）。迈阿密大学已被通知，这项研究与迈阿密大学IRB大学有关，因为Pi of the Pi of该机构。 该存储库还将包含取消识别的样本，这些样本可用于解决与古金博士在先前的NIH资助研究期间收集的与迈阿密大学的艾滋病毒存在有关的问题。 整个存储库将由父母艾滋病毒和老化研究者的协议12492维护和监测。 （AME 7646） 关于将转移到CSMC的NIMH样品： NIMH AIDS计划办公室的副主任Dianne Rausch博士要求PI从该试验中为NIMH维护其余的存储库，并将样品从NIMH的存储库站点转移到CSMC。 NIMH提出的CSMC存储库仅由等离子体，血清和CSF样品组成（这是该试验当前存储库中最初包括的组织类型）。 - 没有个人标识符将与要转移的样本相关联。 - 将编码与从NIMH存储库传输的样本相关联的信息。 -CSMC调查人员将无法访问与其他研究网站信息相关的链接列表。 - 本网站的研究人员只能访问PI先前机构招募的参与者的链接列表。 [该研究完成了PI于2007年移至CSMC之前完成的]。 艾滋病毒和老化研究样本的具体目的是： 血浆，外周血单核细胞以及尿液和细胞涂片的残留样品将被添加到先前存储的样品中，以提供未来的资源，以探索与HIV和衰老相关的其他措施，例如T细胞受体切除回路（TREC），这可能会与胸膜较高的胸膜及其高度的胸膜相互作用之间的相互作用，以及胸膜及其高度及其在胸腔及其高度及其及时的脑之间的相互作用，以及胸腔及时且胸腔及时的持续性，以及胸膜及其高度的静止型，以及胸膜及其高度的静止型，以及胸膜及其及其与胸膜相关性的持续性，以及胸膜及其与胸膜相关性的相互作用。 （称为“ Haart”）。可以预期，可以根据该存储库进行新的研究，以进一步生成实际建议本身的范围。 此外，对与HIV感染的存在/不存在和影响有关的问题，将继续保留现有的血浆，PBMC，尿液，CSF和宫颈涂片。 NIMH存储库中的其余样品（血清，等离子体和CSF）用于这些NIMH HIV/AIDS先验方案之一（NIMH的肽T试验），将转移到CSMC。