Exploratory Pharmcokinetics of UC781 & Tenofovir Vaginal Microbicide Gel V Film
UC781 的探索性药代动力学
基本信息
- 批准号:8660270
- 负责人:
- 金额:$ 37.48万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-06-01 至 2017-05-31
- 项目状态:已结题
- 来源:
- 关键词:Anatomic SitesAnti-Retroviral AgentsBiologicalBiological AssayBiological MarkersBloodBody FluidsCD4 Positive T LymphocytesCellsCellular StructuresClinicalClinical ResearchDataDetergentsDevelopmentDiphosphatesDoseDrug CombinationsDrug ExposureDrug FormulationsDrug KineticsDrug effect disorderFemaleFilmFutureGelGenital systemGrantHIVHIV InfectionsHourHumanImageIndiumLightLiquid substanceMacacaMeasuresModificationMucous MembraneNonoxynol 9OralOutcome StudyParticle SizePatternPenetrationPerformancePermeabilityPharmaceutical PreparationsPharmacodynamicsPhasePlacebosPredispositionPreventiveRadiolabeledRecruitment ActivityResearch DesignResearch PersonnelSamplingScheduleSiteTechnetiumTenofovirTenofovir disoproxil fumarateTestingTimeTissue BankingTissue BanksTissuesToxic effectUC 781VaginaValidationWomanarmcervicovaginalcomparativedrug distributionfallsimprovedmicrobicidenonhuman primateopen labelpharmacodynamic modelradiotracerrectalresearch clinical testingresponsesmall moleculespatiotemporalsuccessvaginal microbicide
项目摘要
The overarching purpose of this Center Grant, "Alternative Formulations of Tenofovir and UC781" is to
develop and compare the performance of two contrasting vaginal microbicide formulation approaches, a gel
and a film, as carriers for an antiretroviral drug combination, UC781 and tenofovir (TFV). This project, Project
4, quantitatively explores the PK domain in exploratory clinical studies by way of direct and non-invasive
sampling of 6 different compartments within the body - fluid and CD4+ cells components both within the
cervicovaginal lumen, cervicovaginal tissues, and blood. The spatlotemporal drug concentration data
gathered will be evaluated in light of pharmacodynamic (PD) data, both efficacy and toxicity, from this and
other Projects within the Center Grant. Armed with this PK-PD data investigators can reach informed
decisions about (1) continued development of these two combination products, (2) potential modifications of
the eventual product candidates tested, and (3) rational study design as the candidates enter formal clinical
testing. To achieve these objective, we have the following 4 specific aims:
Aim 1. Develop and validate assays for UC781, improve tenofovir intracellular assay sensitivity in clinical
samples, and verify compatibility of radiolabels with film formulations (Supports Aim 3 & 4 clinical studies)
Aim 2. Determine the feasibility of using quantitative changes in cervicovaginal permeability to small
molecules and HIV-size particles as a measure of candidate microbicide toxicity: an open label, exploratory
clinical study comparing nonoxynol-9 gel to universal placebo. (Needed for support of Specific Aim 3).
Aim 3. Compare the spatlotemporal distribution (cervicovaginal and systemic) of candidate film and gel
formulations of UC781 (Aim 3-1) and TFV (Aim 3-2): an exploratory clinical study.
Aim 4. Exploratory Human and Macaque PK-PD relationships. Perform drug assays from pharmacodynamic
(efficacy and toxicity) studies in macaques (Project 2) and humans (Project 3) and develop exploratory
pharmacokinetic-pharmacodynamic (PK-PD) models to describe the drug exposure-response relationships
for each candidate microbicide (UC781 and tenofovir) and formulation.
本中心资助“替诺福韦和UC781的替代配方”的总体目的是
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Craig Walter Hendrix其他文献
Craig Walter Hendrix的其他文献
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{{ truncateString('Craig Walter Hendrix', 18)}}的其他基金
Population Pharmacokinetic Modeling and Clinical Trial Simulation to optimize HIV Prevention in Pregnancy and Postpartum
群体药代动力学模型和临床试验模拟可优化妊娠期和产后的艾滋病毒预防
- 批准号:
10316144 - 财政年份:2021
- 资助金额:
$ 37.48万 - 项目类别:
Development of Rectal Enema As Microbicide (DREAM)
直肠灌肠剂作为杀菌剂的开发(DREAM)
- 批准号:
9088326 - 财政年份:2014
- 资助金额:
$ 37.48万 - 项目类别:
Clinical optimization of a tenofovir enema and adherence tracking
替诺福韦灌肠和依从性跟踪的临床优化
- 批准号:
8768695 - 财政年份:2014
- 资助金额:
$ 37.48万 - 项目类别:
Exploratory Pharmcokinetics of UC781 & Tenofovir Vaginal Microbicide Gel V Film
UC781 的探索性药代动力学
- 批准号:
8471644 - 财政年份:2013
- 资助金额:
$ 37.48万 - 项目类别:
The effect of Depo-Provera on HIV susceptibility, immune activation, and PrEP PK
Depo-Provera 对 HIV 易感性、免疫激活和 PrEP PK 的影响
- 批准号:
8588047 - 财政年份:2013
- 资助金额:
$ 37.48万 - 项目类别:
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