Clinical Core

临床核心

• 批准号: 8525441
• 负责人: NED C SACKTOR
• 金额: $ 1.8万
• 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 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8525441
• 关键词: AIDS clinical trial group; AIDS neuropathy; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Americas; Blood specimen; Brain; California; Clinical; Clinical Treatment; Clinical Trials; Cognition Disorders; Data; Development; Disease; Functional disorder; Funding; Goals; Grant; HIV; 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; 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，对于治疗HIV相关神经认知障碍（HAND）的临床试验，没有统一接受的临床、神经影像学或实验室结局指标。本核心的宗旨和目标是：1）提供必要的资源，以继续进行一个充分表征的HIV+和人口统计学匹配的HIV-个体的临床队列，用于评估HAND临床试验的新结果指标和替代标志物的研究，2）与其他NIMH中心或其他参与NeuroAIDS治疗工作的受资助IPCP联络，以帮助确定潜在的候选药物，3）提供设计和进行小型试点研究所需的资源，以评估治疗手的潜在新型化合物，4）维护数据基础设施，以便有效查询临床和实验室数据，5）为涉及中心补助金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财团的联系提供资源。临床结局核心为150名HIV+和50名HIV-个体的队列提供支持，用于评价神经认知和新功能评估。 来自队列参与者的储存CSF和血液标本用于验证替代标志物。 来自临床结局队列的具有良好表征的HAND阶段的参与者用于开发项目。核心还评估了用于治疗HAND的新化合物的安全性、耐受性和疗效结局指标。因此，核心提供了一项服务，以开发用于临床试验的改进的结果测量，并获得候选药物的安全性和耐受性的初步数据。中心还将获得数据，以确定更大规模的有效性确证性研究所需的样本量。