Monitoring Atypical HIV Strains in New Diagnosis

在新诊断中监测非典型 HIV 毒株

• 批准号: 6918204
• 负责人: TRACY L SIDES
• 金额: $ 17.01万
• 依托单位: MINNESOTA STATE DEPT OF HEALTH
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6918204
• 关键词: AIDS /HIV diagnosis; antiAIDS agent; blood tests; clinical research; cooperative study; data collection methodology /evaluation; diagnosis design /evaluation; diagnosis quality /standard; drug resistance; genotype; human immunodeficiency virus; human subject; mathematics; method development; nucleic acid purification; nucleic acid sequence; patient oriented research; polymerase chain reaction; sample collection; serology /serodiagnosis; virus genetics

DESCRIPTION (provided by applicant): This project will contribute towards achieving the following broad goals of the CDC: (1) improve the control and prevention of human immunodeficiency virus (HIV) infection, (2) enhance the health of individuals living with HIV infection, and (3) strengthen the capacity nationwide to monitor the HIV epidemic. The specific overall goals of the project are to (1) evaluate the use of dried blood spots (DBS) as a specimen type for surveillance of atypical strains of HIV, (2) monitor the prevalence of atypical strains of HIV among persons newly diagnosed with HIV, and (3) develop a framework for the implementation of routine atypical HIV strain surveillance. HIV genetic diversity has important public health implications for diagnostic testing, clinical monitoring and treatment, vaccine research and evaluation, and epidemiologic monitoring. An efficacious and cost-effective national surveillance system to monitor antiretroviral drug resistance and divergent subtypes of HIV is greatly needed to inform treatment guidelines, to evaluate the accuracy and reliability of current diagnostic and clinical monitoring assays, and to guide resource allocation and program planning for HIV prevention and care services. Briefly, serum/plasma and/or DBS specimens will be collected from at least 140 unique individuals annually who are newly diagnosed with HIV infection in Minnesota and transported to the Minnesota Department of Health (MDH) Public Health Laboratory. HIV genetic material from the specimens will be amplified, sequenced and evaluated for genotypic evidence of antiretroviral drug resistance and subtype determination. Power calculations based on the anticipated specimen numbers and types from the proposed clinical or laboratory participating sites indicate sufficient power to evaluate (1) the accuracy of DBS compared to sera/plasma for determining HIV drug resistance and subtype as well as (2) the resource efficiency of DBS compared to sera/plasma as a specimen type for atypical HIV strain surveillance. Prevalence estimates will also be made for the populations included in the project. Additionally, MDH staff will collaborate with CDC to produce a series of manuscripts that will review the public health importance of national atypical HIV strain surveillance, propose standard genetic loci to sequence for surveillance purposes, provide a template for annual HIV drug resistance and subtype surveillance data reports, and communicate study results regarding the feasibility and efficiency of DBS as a specimen source for atypical HIV strain surveillance.

描述（由申请人提供）： 该项目将有助于实现疾病预防控制中心的以下广泛目标：（1）改善人类免疫缺陷病毒（HIV）感染的控制和预防，（2）增强艾滋病毒感染者的健康，以及（3）加强全国范围内监测艾滋病毒流行的能力。 该项目的具体总体目标是（1）评估使用干血斑（DBS）作为监测非典型艾滋病毒株的标本类型，（2）监测新诊断艾滋病毒感染者中非典型艾滋病毒株的流行情况，以及（3）制定实施常规非典型艾滋病毒株监测的框架。 HIV遗传多样性对于诊断检测、临床监测和治疗、疫苗研究和评估以及流行病学监测具有重要的公共卫生影响。 非常需要一个有效且具有成本效益的国家监测系统来监测抗逆转录病毒药物耐药性和不同的艾滋病毒亚型，为治疗指南提供信息，评估当前诊断和临床监测分析的准确性和可靠性，并指导艾滋病毒预防和护理服务的资源分配和规划规划。 简而言之，每年将从明尼苏达州新诊断出 HIV 感染的至少 140 名独特个体采集血清/血浆和/或 DBS 样本，并将其运送到明尼苏达州卫生部 (MDH) 公共卫生实验室。 样本中的艾滋病毒遗传物质将被扩增、测序并评估抗逆转录病毒药物耐药性的基因型证据和亚型确定。 基于来自拟议的临床或实验室参与地点的预期样本数量和类型的功效计算表明，有足够的功效来评估（1）与血清/血浆相比，DBS 在确定 HIV 耐药性和亚型方面的准确性，以及（2）与作为非典型 HIV 毒株监测样本类型的血清/血浆相比，DBS 的资源效率。 还将对该项目所包括的人群进行患病率估计。 此外，MDH 工作人员将与 CDC 合作编写一系列手稿，审查国家非典型 HIV 毒株监测的公共卫生重要性，提出用于监测目的的标准基因位点测序，提供年度 HIV 耐药性和亚型监测数据报告的模板，并传达有关 DBS 作为非典型 HIV 毒株监测样本来源的可行性和效率的研究结果。