A Breath-based Medication Adherence Monitoring System for HIV/AIDS Therapies

用于艾滋病毒/艾滋病治疗的基于呼吸的药物依从性监测系统

• 批准号: 7338750
• 负责人: RICHARD J MELKER
• 金额: $ 9.98万
• 依托单位: XHALE, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7338750
• 关键词: AIDS therapy; AIDS/HIV problem; Address; Adherence; African American; Anti-HIV Agents; Antibiotics; Antiviral Agents; Businesses; Characteristics; Chemistry; Communication; Complex; Computer software; Data; Databases; Detection; Development; Devices; Diagnostic; Directly Observed Therapy; Disease; Dose; Drug Kinetics; Drug resistance; Elements; Engineering; Enzymes; Excipients; Exhalation; Eyedrops; Failure; Florida; Foundations; Funding; Gas Chromatography; Gases; Generations; Goals; Gold; Grant; Health; Health Insurance Portability and Accountability Act; Health Personnel; Healthcare; Healthcare Systems; Hispanics; Human; Individual; Industry; Ingestion; Inhalators; Lead; Legal patent; Letters; Licensing; Link; Marketing; Measures; Medical; Metabolism; Methodology; Methods; Monitor; Morbidity - disease rate; National Institute of Mental Health; Numbers; Oral; Organism; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacotherapy; Phase; Physicians; Population; Principal Investigator; Property; Public Health; Qualifying; Rate; Research; Resistance; Risk; Route; Shelter facility; Source; Standards of Weights and Measures; System; Techniques; Technology; Testing; Therapeutic Agents; Time; Treatment Protocols; United States Food and Drug Administration; Universities; Wireless Technology; Work; abstracting; addiction; base; capsule; cost; cost effective; design; detector; drug testing; experience; improved; instrument; medication compliance; mortality; multidisciplinary; novel; pill; programs; prototype; research and development; sensor; transmission process

We propose to design and deploy a handheld breath-based "personal" medication adherence monitoring system (MAMS) which will meet the criteria of the solicitation from the National Institute of Mental Health (NIMH) for "Development of information, instruments or methodologies to improve and/or track adherence to complex HIV/AIDS drug therapies for Hispanic and African American populations". MAMS will consistent of a modified miniature battery powered gas chromatograph (mGC) capable of detecting the presence of a "taggant" or a metabolite of the taggant on the breath of an individual shortly after ingestion of a medication containing it. MAMS will include hardware and software capable of recording the detection of the "taggant", storing the information for later analysis, and notifying, in real-time by wireless or other communications, a healthcare provider if medication is not taken as prescribed. We will explore FDA approved "generally recognized as safe" (GRAS) compounds as taggants. The "taggants" can be applied as a coating to the medication, be added along with the medication to a special capsule or be added as an excipient. We have considerable expertise in the detection of drugs in exhaled breath and are knowledgeable about the properties of candidate "taggants" and their metabolites. Our Specific Aims are: Specific Aim 1: Identify 6-8 chemically diverse taggant candidates from GRAS compound databases that will likely generate appropriate EDIM(s) at doses currently permitted by the FDA in exhaled breath after oral ingestion. Either the taggant or taggant metabolite(s) could qualify as an EDIM. Specific Aim 2: Test whether the GRAS taggant candidates identified in Specific Aim 1 are suitable for MAMS in humans by sequentially analyzing the concentrations of taggant(s) and taggant metabolite(s) in breath after oral ingestion of the taggant using the "gold standard" analytical technique, GC-MS. Specific Aim 3: Design and build a mGC device to reliably measure in real-time the gas phase concentration of two suitable EDIMs identified in Specific Aim 2. Nonadherence to prescribed medication regimens is a major health issue in the US which costs our healthcare system over $100 billion annually. Nonadherence is a major cause of morbidity and mortality. It can result in a public health threat if, for instance, a patient fails to adhere to an antibiotic or antiviral medication. This can lead to the emergence of resistant organisms. We propose to develop a small portable device that a patient can blow into shortly after taking their medication which will detect and document that the appropriate medication was taken at the proper time. This technology should improve adherence rates, especially in high-risk populations.

我们建议设计和部署基于手持呼吸的“个人”药物依从性监测系统（MAMS），该药物将符合美国国家心理健康研究所（NIMH）的招标标准，以“开发信息，工具或方法来改善信息，以改进和/或跟踪对西班牙裔和非裔美国人人口的复杂艾滋病毒/艾滋病药物疗法的依从性”。 MAM将与经过修改的微型电池动力气相色谱仪（MGC）保持一致，能够检测到“ taggant”的存在或在摄入含有它的药物后不久的个体呼吸中的“ taggant”或taggant的代谢物。 MAMS将包括能够记录“ taggant”检测的硬件和软件，存储信息以供以后分析，并通过无线或其他通信实时通知，如果没有按处方进行药物治疗，则医疗保健提供者。我们将探索FDA批准的“通常被认为是安全的”（GRAS）化合物作为标记。可以将“标签者”作为涂层应用于药物，将药物与特殊胶囊一起添加或添加为赋形剂。我们在呼出的呼吸中检测药物方面具有丰富的专业知识，并且对候选人“ taggant”及其代谢物的特性知识渊博。我们的具体目的是：特定目标1：从GRAS化合物数据库中识别6-8个化学多样的标记候选者，这些候选物可能会以FDA目前允许的剂量产生适当的EDIM，以呼出口服后呼气。 Taggant或Taggant代谢物（S）都可以作为EDIM资格。特定目标2：测试特定目标1中确定的gras taggant候选者是否适用于人类中的妈妈，通过依次分析taggant（s）和taggant代谢物（s）的浓度在口服口服使用“金标准）口服后呼吸后呼吸。 “分析技术，GC-MS。特定目标3：设计和建立一个MGC设备，可实时可靠地衡量特定目的2中确定的两个合适EDIM的气相浓度。不遵守处方药治疗方案是美国的主要健康问题每年1000亿美元。不遵守是发病率和死亡率的主要原因。例如，如果患者无法遵守抗生素或抗病毒药物，则可能会导致公共卫生威胁。这可能导致抗性生物的出现。我们建议开发一种小型便携式设备，服用药物后不久就会吹入该设备，该设备可以检测并记录在适当时间服用适当的药物。该技术应提高依从率，尤其是在高风险人群中。

项目成果

Oral adherence monitoring using a breath test to supplement highly active antiretroviral therapy.

• DOI: 10.1007/s10461-012-0318-7
• 发表时间: 2013-01
• 期刊: AIDS AND BEHAVIOR
• 影响因子: 4.4
• 作者: Morey, Timothy E.;Booth, Matthew;Wasdo, Scott;Wishin, Judith;Quinn, Brian;Gonzalez, Daniel;Derendorf, Hartmut;McGorray, Susan P.;Simoni, Jane;Melker, Richard J.;Dennis, Donn M.
• 通讯作者: Dennis, Donn M.