Clinical Core

临床核心

• 批准号: 8525443
• 负责人: NED C SACKTOR
• 金额: $ 31.49万
• 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
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8525443
• 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.

目前尚无对临床试验的临床临床，神经影像或实验室结果指标的治疗，用于治疗HIV相关的神经认知疾病（HAND）。该核心的目标和目标是：1）提供必要的资源，以继续进行临床良好的艾滋病毒+和人口统计学匹配的艾滋病毒个体，以评估新的结果指标和临床试验的替代标记，以供临床试验，2）与其他NIMH中心或其他资金的IPCPS相关的涉及涉及的NIMH中心的疾病，以帮助识别涉及的纳入统治者，以帮助识别涉及的糖尿病，以帮助识别涉及的Neioriations，以帮助识别涉及的nimh中心，以帮助识别涉及的NIMH中心，以帮助识别涉及的NIMH中心，以帮助识别涉及的NIMH中心，以帮助识别涉及的NIMH中心，以帮助识别涉及的NIMH中心。设计和进行小型试点研究以评估潜在的新化合物以治疗手，4）维护数据基础架构，以便对临床和实验室数据有效查询，5）5）为涉及中心赠款资源的研究提供统计支持，6）提供了与正在进行的Neuro-Aids试验的链接的资源。临床结果核心为150 HIV+和50个HIV个体的队列提供了支持，该组合用于评估神经认知和新型功能评估。 储存的CSF和队列参与者的血液标本用于验证替代标记。 从临床成果队列中具有良好特征的手阶段的参与者用于发展项目。核心还评估了新化合物治疗手的安全性，耐受性和有效性结果指标。因此，核心提供了一项服务，以制定改进的临床试验中使用结果指标，并获得有关安全性和耐受性的候选药物的初步数据。核心还将获得数据，以确定较大的疗效确认性研究所需的样本量。