CNS HIV ANTIRETROVIRAL THERAPY EFFECTS RESEARCH (CHARTER)

CNS HIV 抗逆转录病毒治疗效果研究（章程）

• 批准号: 7953662
• 负责人: Susan Morgello
• 金额: $ 6.68万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953662
• 关键词: Antiretroviral resistance; Antiviral Agents; Clinical Research; Competence; Computer Retrieval of Information on Scientific Projects Database; Disease; Drug resistance; Funding; Grant; HIV; HIV Infections; Highly Active Antiretroviral Therapy; Impairment; Incidence; Institution; Measures; Nervous system structure; Neurocognitive; Pathogenesis; Patients; Penetration; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Plasma; Prevalence; Protocols documentation; RNA; Recruitment Activity; Research; Research Personnel; Resources; Risk; Risk Factors; Sampling; Source; Staging; Treatment Protocols; United States; United States National Institutes of Health; Viral; antiretroviral therapy; cognitive function; design; immune RNA; nervous system disorder; neurotoxicity; therapy design

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. With the availability of highly active antiretroviral therapy (HAART), shifts in the spectrum of HIV-related nervous system diseases are being observed. However, there has been no large-scale, comprehensive study of these manifestations and their potential pathogenesis. The CHARTER protocol was designed as an observational, non-interventional study of the nervous system complications of HIV and HAART therapy, designed to encompass a representative sample of HIV-infected patients at 6 subsites across the United States. It will have both cross-sectional and longitudinal components, and will recruit patients in all stages of HIV disease. Hypothesis: HAART will have variable effects on CNS and PNS function, dependent upon the type of regimen and patient-specific factors. Viral replication and drug resistance are important determinants in the longitudinal manifestations of disease. This study will: 1 determine if patients taking HAART have reduced risk of CNS and PNS complications of HIV infection compared to those who are na¿ve to or have stopped prior ARV. 2 determine if the CNS penetration profile of HAART is related to antiviral effects within the CNS (as measured by CSF HIV RNA levels) and to risk of HIV-associated neurological disease (as measured by cognitive function). 3 determine if the mechanism of neurocognitive damage in late stage HIV disease differs from that in earlier stages of HIV disease. 4 measure the relationship of HIV replication within the CNS (as measured by CSF HIV RNA) and of immune competence (as measured by CD4 levels) to the prevalence and incidence of syndromic HIV-related neurocognitive impairment. 5 determine the prevalence of discordant ARV resistance in HIV plasma and CSF. 6 determine if the predictors and risk factors for peripheral neuropathy from HIV differ from that of d-drug ARV neurotoxicity.

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。 随着高度活性抗逆转录病毒疗法（HAART）的可用性，正在观察到与HIV相关的神经系统疾病的变化。但是，没有对这些表现及其潜在发病机理进行大规模的全面研究。宪章方案被设计为对HIV和HAART治疗的神经系统并发症的观察性，无关的研究，旨在涵盖美国6个亚属的HIV感染患者的代表性样本。它将具有横断面和纵向成分，并将在HIV疾病的所有阶段招募患者。 假设：HAART将对中枢神经系统和PNS功能产生可变影响，取决于方案和患者特异性因素的类型。病毒复制和耐药性是疾病纵向表现的重要决定剂。 这项研究将： 1确定服用HAART的患者是否降低了与先前ARV或已停止ARV的患者相比，HIV感染的中枢神经系统和PNS并发症的风险是否降低。 2确定HAART的中枢神经系统渗透率是否与中枢神经系统内的抗病毒作用有关（通过CSF HIV RNA水平测量）和与HIV相关神经系统疾病的风险（通过认知功能测量）。 3确定在晚期HIV疾病疾病的艾滋病毒疾病较早阶段的神经认知损害​​的机制是否差异。 4测量中枢神经系统（通过CSF HIV RNA测量）和免疫能力（通过CD4水平测量）与综合症HIV与HIV相关的神经认知障碍的发生率和发生率的关系。 5确定HIV血浆和CSF中不一致的ARV抗性的患病率。 6确定来自HIV的外周神经病的预测因素和风险因素是否与D-Crug ARV神经毒性不同。