PrEP and ART adherence monitoring using dried blood spots
使用干血斑监测 PrEP 和 ART 依从性
基本信息
- 批准号:8828076
- 负责人:
- 金额:$ 68.34万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2013
- 资助国家:美国
- 起止时间:2013-04-15 至 2016-03-31
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAdolescent Medicine Trials NetworkAntiviral AgentsBloodCaringCharacteristicsChemoprophylaxisClinicalCollectionDataDevelopmentDiabetes MellitusDiagnosisDiphosphatesDirectly Observed TherapyDisadvantagedDoseDrug ExposureDrug FormulationsDrug resistanceElectronicsErythrocytesExhibitsFailureFingersFutureGeneric DrugsGlucoseGlycosylated HemoglobinGoalsHIVHIV SeropositivityHairHalf-LifeHealthHemoglobinHolidaysHumanIndividualInterventionKineticsLocationMeasurementMeasuresMethodsModelingMonitorOutcomeParticipantPatient Self-ReportPatientsPatternPersonsPharmaceutical PreparationsPharmacy facilityPlasmaProcessProdrugsPublic HealthRNARandomizedRecordsRegimenResourcesSafetySiteSpottingsTenofovirTenofovir disoproxil fumarateTestingTherapeuticTimeTranslatingValidationVenipuncturesViremiaVisitantiretroviral therapybasecohortdata modelingdesignefavirenzemtricitabineimprovedmonitoring devicenovelopen labelpillprospectivetherapy adherencevolunteer
项目摘要
DESCRIPTION (provided by applicant): Inadequate adherence to HIV pre-exposure chemoprophylaxis (PrEP) and antiretroviral therapy (ART) is common, and the leading cause of therapeutic failure. Despite this damaging impact on human health, reliable, convenient methods with which to quantify adherence routinely are not available. This application proposes a new quantitative approach to routinely monitor adherence to tenofovir disoproxil fumarate (TDF)-based PrEP and ART. TDF-based regimens are the cornerstone of PrEP and ART with approximately 80% of ART patients and 100% of PrEP patients receiving TDF-based therapy. We discovered that tenofovir-diphosphate (TFV-DP), the active form of TFV, has a 17 day half-life in red blood cells (RBC) with low variability. These characteristics are analogous to glycosylated hemoglobin A1C, which is measured as standard- of-care to quantitatively monitor cumulative glucose exposure for diabetes. We propose that the level of TFV-DP in RBC can be used in a similar way to quantitatively monitor cumulative drug exposure (adherence) for TDF-based PrEP and ART. We showed that the level of TFV-DP in RBC can be quantified using dried blood spots (DBS), which offers significant advantages such as low expense and easy collection and processing requirements. The proposed study will determine the effect of adherence rate on the level of TFV-DP in DBS. Forty eight HIV-negative volunteers will be randomized to 33%, 67% and 100% of daily dosing with TDF-FTC. All dosing will be directly observed therapy (DOT). A randomized incomplete block design with a washout period will be employed such that participants receive 2 of 3 dosing regimens for 12 weeks each. A separate cohort of 32 HIV-positive volunteers will receive daily DOT with TDF-FTC-based therapy. Expected levels of TFV-DP in DBS in the setting of DOT will be defined, compared in HIV-positive versus negative persons, and used to construct a model that predicts adherence quantitatively for PrEP and ART. We will immediately translate our findings to interpret TFV-DP in DBS that are currently being collected for several pivotal PrEP demonstration projects where adherence monitoring is a key outcome. We believe that TFV-DP in DBS, as a new quantitative measure of adherence, has the potential to make an immediate and lasting public health impact.
描述(由申请人提供):HIV暴露前化学预防(PrEP)和抗逆转录病毒治疗(ART)的依从性不足是常见的,也是治疗失败的主要原因。尽管这对人类健康造成了破坏性影响,但目前还没有可靠、方便的方法来常规量化依从性。这一应用提出了一种新的定量方法来常规监测基于富马酸替诺福韦二吡酯(TDF)的PrEP和ART的依从性。基于tdf的方案是PrEP和ART的基础,大约80%的ART患者和100%的PrEP患者接受基于tdf的治疗。我们发现,ttfv的活性形式替诺福韦二磷酸(ttfv - dp)在红细胞(RBC)中的半衰期为17天,具有低可变性。这些特征类似于糖化血红蛋白A1C,作为定量监测糖尿病累积葡萄糖暴露的护理标准。我们建议RBC中ttfv - dp水平可以以类似的方式定量监测基于tdf的PrEP和ART的累积药物暴露(依从性)。我们发现,红细胞中ttv - dp的水平可以用干血点(DBS)来定量,它具有成本低、易于收集和处理等显著优势。拟议的研究将确定依从率对DBS中ttv - dp水平的影响。48名hiv阴性志愿者将被随机分为33%、67%和100%的TDF-FTC每日剂量。所有给药将直接观察治疗(DOT)。采用随机的不完全区组设计和洗脱期,使参与者接受3种给药方案中的2种,每种方案12周。另一组由32名hiv阳性志愿者组成的队列将每天接受DOT和基于tdf - ftc的治疗。将定义DOT环境下DBS中ttv - dp的预期水平,比较hiv阳性和阴性患者,并用于构建定量预测PrEP和ART依从性的模型。我们将立即将我们的发现转化为DBS中的ttfv - dp,这些ttfv - dp目前正在为几个关键的PrEP示范项目收集,其中依从性监测是一个关键结果。我们认为,DBS中的ttv - dp作为一种新的依从性定量测量方法,有可能对公共卫生产生直接和持久的影响。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
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PETER L. ANDERSON其他文献
PETER L. ANDERSON的其他文献
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{{ truncateString('PETER L. ANDERSON', 18)}}的其他基金
A platform for monitoring the efficacy and optimal dosing of long-acting ART
用于监测长效 ART 疗效和最佳剂量的平台
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10546923 - 财政年份:2022
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$ 68.34万 - 项目类别:
A platform for monitoring the efficacy and optimal dosing of long-acting ART
用于监测长效 ART 疗效和最佳剂量的平台
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10661822 - 财政年份:2022
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$ 68.34万 - 项目类别:
PrEP adherence-concentration thresholds associated with HIV protection among African women
非洲妇女中与艾滋病毒保护相关的 PrEP 坚持浓度阈值
- 批准号:
10155163 - 财政年份:2021
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$ 68.34万 - 项目类别:
Optimizing PrEP regimens for pregnant women in sub-Saharan Africa
优化撒哈拉以南非洲孕妇的 PrEP 方案
- 批准号:
10254548 - 财政年份:2021
- 资助金额:
$ 68.34万 - 项目类别:
Optimizing PrEP regimens for pregnant women in sub-Saharan Africa
优化撒哈拉以南非洲孕妇的 PrEP 方案
- 批准号:
10395611 - 财政年份:2021
- 资助金额:
$ 68.34万 - 项目类别:
Optimizing PrEP regimens for pregnant women in sub-Saharan Africa
优化撒哈拉以南非洲孕妇的 PrEP 方案
- 批准号:
10595529 - 财政年份:2021
- 资助金额:
$ 68.34万 - 项目类别:
PrEP adherence-concentration thresholds associated with HIV protection among African women
非洲妇女中与艾滋病毒保护相关的 PrEP 坚持浓度阈值
- 批准号:
10560498 - 财政年份:2021
- 资助金额:
$ 68.34万 - 项目类别:
New Pharmacologic Measures of ART Adherence and Exposure: Pathway to Clinical Implementation
ART 依从性和暴露的新药理学措施:临床实施途径
- 批准号:
10378506 - 财政年份:2019
- 资助金额:
$ 68.34万 - 项目类别:
New Pharmacologic Measures of ART Adherence and Exposure: Pathway to Clinical Implementation
ART 依从性和暴露的新药理学措施:临床实施途径
- 批准号:
10611354 - 财政年份:2019
- 资助金额:
$ 68.34万 - 项目类别:
PrEP and ART adherence monitoring using dried blood spots
使用干血斑监测 PrEP 和 ART 依从性
- 批准号:
8544659 - 财政年份:2013
- 资助金额:
$ 68.34万 - 项目类别:
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