A Breath-based Medicaton Adherence Monitoring System for HIVAIDS Therapies

用于艾滋病治疗的基于呼吸的药物依从性监测系统

• 批准号: 7921940
• 负责人: RICHARD J MELKER
• 金额: $ 79.51万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7921940
• 关键词: 2-butanol; AIDS therapy; AIDS/HIV problem; Academia; Achievement; Adherence; Adverse event; Algorithms; Antibiotics; Antiviral Agents; Archives; Area; Behavioral; Biological; Blood; Butanones; Chemicals; Chemistry; Clinical Trials; Collection; Contracts; Data; Data Set; Deglutition; Detection; Development; Device Designs; Devices; Drug Kinetics; Electronics; Evaluation; Exhalation; Fasting; Food; Future Generations; Gas Chromatography; Gases; Grant; Guidelines; Health; Health Care Costs; Health Personnel; Healthcare Systems; Highly Active Antiretroviral Therapy; Human; Individual; Industry; Information Technology; Ingestion; International; Lead; Link; Manufacturer Name; Mass Spectrum Analysis; Measures; Metabolism; Methodology; Methods; Monitor; Morbidity - disease rate; Oral; Organism; Pathway interactions; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Pharmacy facility; Phase; Pilot Projects; Population; Principal Investigator; Public Health; Regimen; Reporting; Research; Resistance; Safety; Site; System; Techniques; Technology; Testing; Therapeutic; Time; United States National Institutes of Health; antiretroviral therapy; base; computerized data processing; cost; design; drug discovery; fight against; high risk; improved; medication compliance; metal oxide; mortality; new technology; prevent; programs; prototype; public health relevance; resistant strain; sensor; symposium; usability

DESCRIPTION (provided by applicant): Building on our Phase I achievements, we will design and deploy a handheld, breath-based medication adherence monitoring system (adherence system) to identify adherence for clinical trials. The system consists of a miniature, battery powered gas chromatograph (the device) capable of measuring volatile metabolites (e.g., butanone) on an individual's breath after ingestion of a medication containing taggants (e.g., 2-butanol). This data can be sent to and evaluated by health care personnel via HIPAA-compliant information technology to allow opportunity to improve medication adherence. In Phase II activities, we propose a plan to optimize the design of the adherence system. The proposal consists of 7 aims. Specific Aim 1: Chemistry - characterize "generally recognized as safe" taggants for definitive adherence in humans. a) Determine breath pharmacokinetic parameters of two definitive taggants and their key volatile metabolites in fasting humans (months 1-6), and b) create a chemistry backup program to develop new definitive taggants (months 1-24). [Specific Aim 2: Food Interference - further validate that food does not interfere with this adherence system (months 6-12)]. Note: new aims are bracketed and in Georgia font. Specific Aim 3: Pharmacy - optimize the means whereby taggants are interfaced to pharmaceutical products for definitive adherence (months 1-24). Specific Aim 4: Portable Gas Sensor - finalize design of the mGC-MOS, a) optimize mGC and MOS components of mGC-MOS unit, b) design, implement and optimize a breath collection device, and c) identify a contract manufacturer (months 1-12). [Specific Aim 5: Information Technology and Data Processing - develop methods and techniques to locally store, transmit, remotely archive, and distribute adherence data in a HIPAA-compliant manner. Develop signal processing algorithms to improve taggant detection accuracy of device. (months 1-12) Specific Aim 6: Adherence System Accuracy - Conduct a pilot study in humans to test system performance (months 12-18). Specific Aim 7: Behavioral (Usability) Adherence System Evaluation - Conduct a pilot study in high risk, HIV/AIDS patients to test acceptance of the system (months 18-24).] The ability to stratify medication adherence rates to safety and efficacy parameters and linking adverse events to medication ingestion will lead to optimal decisions regarding clinical trial drugs safety and efficacy. PUBLIC HEALTH RELEVANCE: 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, and provide pharmaceutical companies and the FDA with an improved data set for evaluating drugs in clinical trials.

描述（由申请人提供）：在我们的第一阶段成就上，我们将设计和部署基于呼吸的药物依从性监测系统（依从性系统），以识别临床试验的依从性。该系统由一个微型，电池动力的气相色谱仪（设备）组成，能够在摄入含有标记的药物（例如2-叔丁醇）后，能够在个人的呼吸上测量挥发性代谢物（例如丁酮）。这些数据可以通过兼容HIPAA的信息技术发送给医疗保健人员并评估并评估，以允许机会改善药物依从性。在第二阶段的活动中，我们提出了一项计划，以优化依从性系统的设计。该提案包括7个目标。特定目的1：化学 - 特征是“通常被认为是安全的”标签，以确保人类的确定性。 a）确定在禁食人（1-6个月）中，两个确定性标签者的呼吸药代动力学参数及其关键的挥发性代谢物，b）创建一个化学备份程序来开发新的确定性标签者（1-24个月）。 [特定目的2：食物干扰 - 进一步验证食物不会干扰这种依从性系统（第6-12个月）]。注意：新目标是包围的，在佐治亚州字体中。特定目标3：药房 - 优化标记与药品粘附的药品相连的平均值（1-24个月）。特定目标4：便携式气体传感器 - MGC-MOS的最终设计，a）优化MGC-MOS单元的MGC和MOS组件，b）设计，实施和优化呼气收集设备，C）确定合同制造商（1-12个月）。 [特定目标5：信息技术和数据处理 - 开发以符合HIPAA的方式在本地存储，传输，远程存档和分发依从性数据的方法和技术。开发信号处理算法以提高设备的标记检测精度。 （1-12个月）具体目标6：依从性系统精度 - 在人类中进行试点研究以测试系统性能（第12-18个月）。具体目的7：行为（可用性）依从性系统评估 - 进行高风险的试点研究，HIV/AIDS患者测试对系统的接受（第18-24个月）。公共卫生相关性：在美国，不遵守处方药物方案是一个主要的健康问题，每年耗费我们的医疗保健系统超过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，并为制药公司和FDA提供改进的数据集，以评估临床试验中的药物。

项目成果

Feasibility of a breath test for monitoring adherence to vaginal administration of antiretroviral microbicide gels.

呼气测试监测抗逆转录病毒杀菌剂凝胶阴道给药依从性的可行性。

• DOI: 10.1177/0091270011434157
• 发表时间: 2013
• 期刊: Journal of clinical pharmacology
• 影响因子: 2.9
• 作者: Morey,TimothyE;Wasdo,Scott;Wishin,Judith;Quinn,Brian;vanderStraten,Ariane;Booth,Matthew;Gonzalez,Daniel;Derendorf,Hartmut;Melker,RichardJ;Dennis,DonnM
• 通讯作者: Dennis,DonnM