Monitoring Atypical HIV Strains in New Diagnosis

在新诊断中监测非典型 HIV 毒株

• 批准号: 7115930
• 负责人: TRACY L SIDES
• 金额: $ 16.87万
• 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/7115930
• 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控制和预防中心的以下广泛目标：（1）改善对人体免疫缺陷病毒（艾滋病毒）感染的控制和预防，（2）改善艾滋病毒感染者的健康，（3）加强全国监测艾滋病毒流行病的能力。 该项目的具体总体目标是：（1）评价干血斑作为监测非典型艾滋病毒株标本的使用情况;（2）监测新诊断的艾滋病毒感染者中非典型艾滋病毒株的流行情况;（3）制定实施非典型艾滋病毒株例行监测的框架。 艾滋病毒遗传多样性对诊断检测、临床监测和治疗、疫苗研究和评价以及流行病学监测具有重要的公共卫生意义。 非常需要一个有效和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艾滋病毒的不同亚型，以告知治疗指南，评估当前诊断和临床监测检测的准确性和可靠性，并指导艾滋病毒预防和护理服务的资源分配和方案规划。 简言之，每年将从明尼苏达州至少140例新诊断为HIV感染的独特个体中采集血清/血浆和/或DBS标本，并运送至明尼苏达州卫生部（MDH）公共卫生实验室。 将对标本中的HIV遗传物质进行扩增、测序并评价抗逆转录病毒药物耐药性的基因型证据和亚型确定。 基于拟定临床或实验室参与研究中心的预期标本数量和类型的把握度计算表明，有足够的把握度来评价（1）DBS与血清/血浆相比在确定HIV耐药性和亚型方面的准确性，以及（2）DBS与血清/血浆相比作为非典型HIV毒株监测的标本类型的资源效率。 还将对该项目所包括的人口进行流行率估计。 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，提出标准遗传基因座测序用于监测目的，为年度HIV耐药性和亚型监测数据报告提供模板，并交流关于DBS作为非典型HIV毒株监测标本来源的可行性和有效性的研究结果。