Clinical Core

临床核心

• 批准号: 8879205
• 负责人: NED C SACKTOR
• 金额: $ 38.87万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-16 至 2017-05-07
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8879205
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Americas; Blood specimen; Brain; California; Clinical; Clinical Treatment; Clinical Trials; Cognition Disorders; Data; Development; Functional disorder; Funding; Goals; Grant; HIV; HIV-associated neurocognitive disorder; Individual; Inflammation; Institutes; Laboratories; National Institute of Mental Health; Neurocognitive; Outcome; Outcome Measure; Participant; Phase; Pilot Projects; Research; Research Infrastructure; Resources; Safety; Sample Size; Science; Services; Staging; Surrogate Markers; System; Therapeutic; United States National Institutes of Health; Universities; Work; cohort; design; drug candidate; global health; improved; neuroAIDS; neuroimaging; novel; novel strategies; novel therapeutics; scale up

There currently are no uniformly accepted clinical, neuroimaging, or laboratory outcome measures for clinical trials for the treatment of HIV associated neurocognitive disorders (HAND). The goals and objectives of this Core are: 1) to provide the resources necessary to continue a clinical cohort of well-characterized HIV+ and demographically-matched HIV- individuals for studies evaluating new outcome measures and surrogate markers for clinical trials of HAND, 2) to liaise with other NIMH Centers or other funded IPCPs involved in NeuroAIDs therapeutic work to help identify potential candidate agents, 3) to provide the resources necessary to design and conduct small pilot studies to evaluate potential novel compounds to treat HAND, 4) to maintain a data infrastructure to allow for efficient querying of clinical and laboratory data, 5) to provide statistical support for studies involving the Center Grant resources, 6) to provide a resource for linkage with ongoing Neuro-AIDS trial consortia. The Clinical Outcomes Core provides support for a cohort of 150 HIV+ and 50 HIV- individuals which is used to evaluate both neurocognitive and novel functional assessments. Stored CSF and blood specimens from cohort participants are used to validate surrogate markers. Participants with a well characterized HAND stage from the Clinical Outcomes Cohort are used for developmental projects. The Core also evaluates safety, tolerability, and efficacy outcome measures for new compounds for the treatment of HAND. Thus, the Core provides a service to develop improved outcome measures for use in clinical trials, and obtains preliminary data for candidate drugs of safety and tolerability. The Core will also obtain data to determine the sample size needed for larger, confirmatory studies of efficacy.

目前，对于HIV相关性神经认知障碍(HAND)的临床试验，还没有统一接受的临床、神经成像或实验室结果衡量标准。这一核心的目标和目的是：1)提供必要的资源，以继续进行具有良好特征的艾滋病毒+和人口统计学匹配的艾滋病毒个人的临床队列研究，以评估HAND临床试验的新结果衡量标准和替代标记物；2)与参与神经艾滋病治疗工作的其他NIMH中心或其他受资助的IPCP联系，以帮助确定潜在的候选药物；3)提供必要的资源，以设计和进行小型试点研究，以评估治疗HAND的潜在新化合物；4)维护数据基础设施，以允许高效查询临床和实验室数据；5)为涉及中心赠款资源的研究提供统计支持，6)为与正在进行的神经艾滋病试验联合体建立联系提供资源。临床结果核心为150名艾滋病毒阳性患者和50名艾滋病毒阳性患者提供支持，用于评估神经认知和新的功能评估。 储存的脑脊液和队列参与者的血液样本被用来验证替代标志物。 临床结果队列中具有良好手部阶段特征的参与者被用于开发项目。CORE还评估用于治疗手部疾病的新化合物的安全性、耐受性和有效性结果衡量标准。因此，该中心提供了一项服务，以开发用于临床试验的改进的结果衡量标准，并获得候选药物的安全性和耐受性的初步数据。核心还将获得数据，以确定对疗效进行更大规模验证性研究所需的样本量。