A low-profile copper intrauterine device that delivers long-acting contraception an
一种低调的铜宫内节育器,可提供长效避孕和
基本信息
- 批准号:10675641
- 负责人:
- 金额:$ 73.97万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-09-16 至 2025-08-31
- 项目状态:未结题
- 来源:
- 关键词:AIDS preventionAddressAdherenceAlloysAnatomyAnti-Retroviral AgentsAntiviral AgentsAtopobium vaginaeBenchmarkingBiopsyCellsCervicalCervix UteriChemicalsCirculationClinicalClinical DataContraceptive AgentsContraceptive methodsCopperCopper Intrauterine DevicesCytologyDataDevelopmentDevice DesignsDevicesDoseDrug Delivery SystemsDrug FormulationsDrug KineticsDrug resistanceElectrospinningEndocervixEndometrialEndometriumEthylenesExocervixFDA approvedFemaleHIVHIV-1HIV/AIDSHealthHealth PrioritiesHormonesHumanInflammatoryInjectableIntrauterine DevicesLeadLevonorgestrelLicensingMacacaMacaca mulattaMeasurementMeasuresMemoryMethodsModelingMonitorMucous MembraneOperative Surgical ProceduresOralPapioPermeabilityPharmaceutical PreparationsPharmacologic SubstancePlasmaPolyurethanesPositioning AttributePregnancyPreventionPrevention strategyProdrugsProteinsRecording of previous eventsReportingReproductive HealthSafetySerumShapesSiteSolidSolubilityStudy modelsSurgical suturesSystemSystemic infectionTechnologyTissuesUterine cavityUterusVaginaViralWidthWomancervicovaginalcontraceptive efficacycytokinedrug efficacyefficacy evaluationefficacy studyempowermentflexibilityglobal healthimplantable deviceinnovationmicrobicidemicrobiotanext generationnovelpandemic diseasepolydimethylsiloxanepre-exposure prophylaxispreventprotective efficacyprototypesexual HIV transmissionsimian human immunodeficiency virussuccesstransmission processtreatment as preventionultrasoundunintended pregnancyuser-friendlyvinyl acetate
项目摘要
ABSTRACT
The dual impacts of the HIV/AIDS pandemic and unintended pregnancies constitute a major health burden for
women worldwide and justify the development of highly-effective next-generation multipurpose prevention
technologies (NGM) that combine safe, effective, and easily reversible long-acting contraception with HIV
prevention. Here, we propose to adapt a memory wire copper intrauterine device (IUD) frame as a platform for
intrauterine delivery of antiretroviral (AVR) drugs to provide user friendly HIV pre-exposure prophylaxis (PrEP)
and contraception. We propose to evaluate ARV drug delivery systems compatible with IUD delivery for duel-
protection up to three years. In Aim 1, we will formulate candidate antiviral drug/prodrug solid dispersions in
matrix, reservoir and electrospun drug delivery systems and integrate these into an existing copper IUD to
optimize drug loading, dissolution rate, chemical and functional stability, and stable integration with and
functional attributes of the IUD. We will then evaluate the safety and pharmacokinetic effects of intrauterine
delivery of candidate devices in baboons, and measure drug concentrations in the vagina, cervix, and
endometrium. Finally, in Aim 3 we will use the macaque model to evaluate the protective efficacy of the drug-
eluting delivery system for HIV pre-exposure prophylaxis against a repeated low-dose vaginal SHIV162P3
challenge.
摘要
艾滋病毒/艾滋病大流行和意外怀孕的双重影响是#年的主要健康负担。
并证明开发高效的下一代多用途预防措施是合理的
将安全、有效和易于逆转的长效避孕与艾滋病毒相结合的技术(NGM)
预防。在这里,我们建议采用记忆丝铜宫内节育器(IUD)框架作为平台
宫内交付抗逆转录病毒(AVR)药物以提供用户友好的艾滋病毒暴露前预防(PrEP)
和避孕措施。我们建议评估ARV给药系统与IUD给药系统在对决中的兼容性。
保护期限最高可达三年。在目标1中,我们将在以下方面制备候选抗病毒药物/前药物固体分散体
基质、储器和电纺药物输送系统,并将这些系统集成到现有的铜质IUD中,以
优化载药量、溶出度、化学稳定性和功能稳定性,并与药物稳定结合
宫内节育器的功能属性。然后我们将评估宫内注射的安全性和药代动力学效应。
在狒狒体内传递候选装置,并测量阴道、宫颈和子宫中的药物浓度
子宫内膜。最后,在目标3中,我们将使用猕猴模型来评估药物的保护效果--
用于HIV暴露前预防重复小剂量阴道注射SHIV162P3的洗脱递送系统
挑战。
项目成果
期刊论文数量(4)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Drug Eluting Embolization Particles for Permanent Contraception.
- DOI:10.1021/acsbiomaterials.2c00357
- 发表时间:2022-07-11
- 期刊:
- 影响因子:5.8
- 作者:VanBenschoten, Hannah;Yao, Shan;Jensen, Jeffrey T.;Woodrow, Kim A.
- 通讯作者:Woodrow, Kim A.
Vaginal delivery of vaccines.
- DOI:10.1016/j.addr.2021.113956
- 发表时间:2021-11
- 期刊:
- 影响因子:16.1
- 作者:VanBenschoten HM;Woodrow KA
- 通讯作者:Woodrow KA
Medical Applications of Porous Biomaterials: Features of Porosity and Tissue-Specific Implications for Biocompatibility.
多孔生物材料的医学应用:孔隙度特征和生物相容性的组织特异性影响。
- DOI:10.1002/adhm.202102087
- 发表时间:2022-05
- 期刊:
- 影响因子:10
- 作者:
- 通讯作者:
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JEFFREY T. JENSEN其他文献
JEFFREY T. JENSEN的其他文献
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{{ truncateString('JEFFREY T. JENSEN', 18)}}的其他基金
A low-profile copper intrauterine device that delivers long-acting contraception an
一种低调的铜宫内节育器,可提供长效避孕和
- 批准号:
10264922 - 财政年份:2020
- 资助金额:
$ 73.97万 - 项目类别:
A low-profile copper intrauterine device that delivers long-acting contraception an
一种低调的铜宫内节育器,可提供长效避孕和
- 批准号:
10158876 - 财政年份:2020
- 资助金额:
$ 73.97万 - 项目类别:
A low-profile copper intrauterine device that delivers long-acting contraception an
一种低调的铜宫内节育器,可提供长效避孕和
- 批准号:
10460638 - 财政年份:2020
- 资助金额:
$ 73.97万 - 项目类别:
PHOSPHODIESTERASE 3 INHIBITORS: BLOCKERS OF OOCYTE MATURATION AND FERTILIZATION
磷酸二酯酶 3 抑制剂:卵母细胞成熟和受精的阻断剂
- 批准号:
8357748 - 财政年份:2011
- 资助金额:
$ 73.97万 - 项目类别:
TRANSCERVICAL POLIDOCANOL FOAM AS NONSURGICAL FEMALE STERILIZATION TECHNIQUE
经宫颈聚多醇泡沫作为非手术女性绝育技术
- 批准号:
8357847 - 财政年份:2011
- 资助金额:
$ 73.97万 - 项目类别:
PHOSPHODIESTERASE 3 INHIBITORS: BLOCKERS OF OOCYTE MATURATION AND FERTILIZATION
磷酸二酯酶 3 抑制剂:卵母细胞成熟和受精的阻断剂
- 批准号:
8173196 - 财政年份:2010
- 资助金额:
$ 73.97万 - 项目类别:
PHOSPHODIESTERASE 3 INHIBITORS: BLOCKERS OF OOCYTE MATURATION AND FERTILIZATION
磷酸二酯酶 3 抑制剂:卵母细胞成熟和受精的阻断剂
- 批准号:
7958433 - 财政年份:2009
- 资助金额:
$ 73.97万 - 项目类别:
PHOSPHODIESTERASE 3 INHIBITORS: BLOCKERS OF OOCYTE MATURATION AND FERTILIZATION
磷酸二酯酶 3 抑制剂:卵母细胞成熟和受精的阻断剂
- 批准号:
7715903 - 财政年份:2008
- 资助金额:
$ 73.97万 - 项目类别:
PHOSPHODIESTERASE 3 INHIBITORS: BLOCKERS OF OOCYTE MATURATION AND FERTILIZATION
磷酸二酯酶 3 抑制剂:卵母细胞成熟和受精的阻断剂
- 批准号:
7561913 - 财政年份:2007
- 资助金额:
$ 73.97万 - 项目类别:
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