Pooled Nucleic Acid Testing to Identify Antiretroviral Treatment Failure in India

印度进行汇总核酸检测以确定抗逆转录病毒治疗失败

• 批准号: 7684880
• 负责人: David Mitchell Smith
• 金额: $ 17.79万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7684880
• 关键词: Adherence; Algorithms; Anti-Retroviral Agents; Antiretroviral resistance; Biological Assay; Blood specimen; Characteristics; Clinic; Clinical Trials; Collaborations; Country; Data; Drug resistance; Enrollment; Epidemic; Evolution; Failure; Funding Mechanisms; Future; Goals; HIV; Incidence; India; Individual; Life; Measures; Methods; Monitor; Nucleic Acid Amplification Tests; Outcome Measure; Participant; Patient Self-Report; Patients; Plasma; Population Group; Predictive Value; Prevalence; RNA; Regimen; Relative (related person); Reporting; Research; Research Infrastructure; Research Personnel; Resolution; Resources; Risk; Sampling; Sampling Studies; Screening procedure; Simulate; Technical Expertise; Testing; Time; Treatment Failure; United States; Viral Load result; Visual; analog; antiretroviral therapy; base; clinical care; cost; improved; novel; novel strategies; programs; research study; success; therapy adherence

DESCRIPTION (provided by applicant): When antiretroviral therapy (ART) fails to suppress HIV replication, drug resistance can develop and be transmitted. This can be particularly devastating in resource limited settings where only a few ART regimens are available. The overarching aims of this proposal are to enhance a productive collaboration between UCSD and investigators in Chennai, India and to evaluate unique cost-containing methods for viral load monitoring of Indian patients on first-line ART. Specifically, we will enroll 500 HIV-infected patients followed at a HIV clinic in Chennai, India for monitoring of virologic failure of first-line ART. We will evaluate three approaches of nucleic acid testing (NAT) for HIV RNA: 1) individual samples, 2) minipools of 5 samples, and 3) 10x10 sample pooling matrix. Innovatively, the pooling methods make use of the quantitative information that is available from the viral loads to identify individual samples with virologic failure within the platforms of pooled samples. We will define the test characteristics of each method including: accuracy, efficiency, result turn-around time and costs, and we will determine if simple adherence measures can improve these test characteristics. These experiments will also allow us to define the prevalence of virologic failure in this study population group. Taken together, the generated data will serve as the basis for choosing a sustainable method for monitoring for virologic failure in Southern India. PUBLIC HEALTH RELEVANCE: We still struggle with availability of effective antiretroviral therapy and CD4 monitoring in most parts of the world where most of the people infected with HIV live. In these settings, the availability of viral load monitoring is practically unattainable for the vast majority of patients, often because of the lack of infrastructure and technical expertise. Even when infrastructure and expertise exist, cost prohibits its use. We propose in this application to evaluate the test characteristics of novel methods that may ultimately bring viral load monitoring to resource-limited settings.

描述（由申请人提供）：当抗逆转录病毒疗法（ART）无法抑制HIV复制时，可以发展和传播耐药性。在仅有少数艺术方案的资源设置中，这可能尤其是毁灭性的。该提案的总体目的是增强印度钦奈的UCSD与研究人员之间的富有成效的合作，并评估印度患者在一线艺术中对印度患者进行病毒负荷监测的独特含量的方法。具体而言，我们将在印度钦奈的一家HIV诊所招募500名HIV感染患者，以监测一线ART病毒学衰竭。我们将评估HIV RNA的核酸测试（NAT）的三种方法：1）单个样本，2）5个样品的微型和3）10x10样品池基质。创新的是，合并方法利用了从病毒载荷可用的定量信息来识别合并样品平台内病毒学衰竭的单个样本。我们将定义每种方法的测试特性，包括：准确性，效率，结果转折时间和成本，我们将确定简单的依从性测量是否可以改善这些测试特征。这些实验还将使我们能够定义该研究人群中病毒学衰竭的流行率。综上所述，生成的数据将是选择一种可持续方法来监测印度南部病毒衰竭的基础。公共卫生相关性：我们仍然在世界上大多数地方的大多数感染HIV Live的人的大部分地区都为有效的抗逆转录病毒疗法和CD4监测而苦苦挣扎。在这些情况下，通常由于缺乏基础设施和技术专长，对绝大多数患者的病毒负荷监测的可用性实际上是无法实现的。即使存在基础设施和专业知识，COST也禁止其使用。我们在此应用中建议评估新方法的测试特征，这些方法可能最终将病毒载荷监测带入资源有限的设置。