Ultra-Long-Acting Polymeric Injectable Multi-Purpose Prevention Technology for Contraception and HIV Prevention
用于避孕和艾滋病毒预防的超长效聚合物注射多用途预防技术
基本信息
- 批准号:10392508
- 负责人:
- 金额:$ 76.91万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-04-13 至 2026-03-31
- 项目状态:未结题
- 来源:
- 关键词:AIDS preventionAccelerated PhaseAddressAdverse eventAffinityAfricaAnimal ModelAnti-Retroviral AgentsCenters for Disease Control and Prevention (U.S.)CervicalCharacteristicsContraceptive AgentsContraceptive UsageContraceptive methodsCopper Intrauterine DevicesCountryDataDevelopmentDrug Delivery SystemsDrug DesignDrug ImplantsDrug KineticsEngineeringEpidemicEtonogestrelEvaluationEventExcipientsFemaleFormulationFosteringGoalsGrantHIVHIV InfectionsHIV riskHIV/STDHealth BenefitImplantIn SituIn VitroInbred BALB C MiceIncidenceInfectionInjectableInjectionsIntramuscularLeadLiquid substanceMacacaMacaca nemestrinaMeasuresMedroxyprogesterone 17-AcetateMethodsModelingMucous MembraneOralPatientsPerformancePharmaceutical PreparationsPharmacologyPlacebosPlasmaPolymersPregnancyPreventionProcessProgestinsPropertyProphylactic treatmentPublic HealthRegimenResearch PersonnelSafetySexual TransmissionSubcutaneous InjectionsSuspensionsTailTechnologyTestingTimeTissuesToxic effectUser ComplianceVaginaWomanallergic responsebreakthrough infectionchemical propertycontrolled releasecost effectivedesigndrug release kineticsefficacy evaluationefficacy studyexperiencehigh riskimplant designin vivoinnovationmennanoformulationnanoparticlenonhuman primatenovelnovel therapeuticspathogenpharmacometricspre-clinicalpre-exposure prophylaxispregnancy preventionpreventprophylacticsexsimian human immunodeficiency virustooltransmission processunintended pregnancyviral transmission
项目摘要
PROJECT SUMMARY
Globally, over 50% of those infected with HIV are women, and annually, ~50% of all pregnancies are unplanned.
Therefore, there is a critical need to promote female-controlled methods of multipurpose prevention technologies
(MPTs) and delivery strategies that can be disassociated from the sex act. Injectable formulations are well
tolerated by men and women, are efficacious for contraception, and have high patient acceptability and
compliance1-4. Innovations recently introduced into the field of systemic PrEP are long-acting (LA) formulations
of antiretrovirals (ARVs) that stably release drugs over many weeks as nano-formulations and have activity in
animal models of prevention5-7 and in humans8-10. Currently, there are two different LA formulations being
considered for HIV prevention: a LA form of rilpivirine (RPV/TMC278) and a LA form of cabotegavir
(CAB/GSK744)9, 11-12. Injections of these LA ARVs requires a 4-week ‘lead-in’ regimen using oral cabotegravir or
rilpivirine to fulfil current safety considerations as once injected these agents have detectable levels for months
and the drug cannot be removed or have its clearance accelerated. Despite these advances in HIV PrEP,
currently there are no LA injectable MPT formulations in development mainly because of limitations of current
LA injectable formulations utilizing nanoparticle suspensions whereby two drugs cannot be combined into a
single injection. In this R01 grant and building on our existing data, we propose a comprehensive evaluation of
a first-in-line injectable MPT that offers durable and sustained protection from HIV transmission, high efficacy of
contraception, increased user compliance, and the ability to be removed in case of unanticipated adverse events
or when considering discontinuation from the LA HIV PrEP and/or contraception. We will achieve this goal by
developing a liquid MPT formulation utilizing excipients that form a biodegradable depot after subcutaneous
injection (in-situ forming implant (ISFI)). We propose a comprehensive evaluation of this novel drug delivery
approach using a highly relevant macaque model of mucosal simian/human immunodeficiency virus (SHIV) as
an invaluable preclinical tool to assess the efficacy of the ISFI against SHIV acquisition. This cutting-edge
combined approach will be utilized to evaluate the scientific premise of our proposal to investigate whether
sustained protection against HIV acquisition and pregnancy can be achieved using a unique and highly
innovative ultra-long-acting coitally-independent MPT ISFI formulation.
项目总结
项目成果
期刊论文数量(0)
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科研奖励数量(0)
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Soumya Rahima Benhabbour其他文献
Soumya Rahima Benhabbour的其他文献
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{{ truncateString('Soumya Rahima Benhabbour', 18)}}的其他基金
Ultra-long-acting Biodegradable and Tunable Polymeric Solid Implant for HIV Treatment Maintenance
用于维持艾滋病毒治疗的超长效可生物降解和可调聚合物固体植入物
- 批准号:
10759149 - 财政年份:2023
- 资助金额:
$ 76.91万 - 项目类别:
Mucoadhesive film for the treatment of vestibulodynia
治疗前庭痛的粘膜粘附膜
- 批准号:
10699463 - 财政年份:2023
- 资助金额:
$ 76.91万 - 项目类别:
Ultra-Long-Acting Polymeric Injectable Multi-Purpose Prevention Technology for Contraception and HIV Prevention
用于避孕和艾滋病毒预防的超长效聚合物注射多用途预防技术
- 批准号:
10258079 - 财政年份:2021
- 资助金额:
$ 76.91万 - 项目类别:
Ultra-Long-Acting Polymeric Injectable Multi-Purpose Prevention Technology for Contraception and HIV Prevention
用于避孕和艾滋病毒预防的超长效聚合物注射多用途预防技术
- 批准号:
10583510 - 财政年份:2021
- 资助金额:
$ 76.91万 - 项目类别:
Next Generation Multipurpose Intravaginal Ring Technology Using Innovative CLIP 3D Printing
采用创新 CLIP 3D 打印的下一代多用途阴道环技术
- 批准号:
10540359 - 财政年份:2019
- 资助金额:
$ 76.91万 - 项目类别:
Next Generation Multipurpose Intravaginal Ring Technology Using Innovative CLIP 3D Printing
采用创新 CLIP 3D 打印的下一代多用途阴道环技术
- 批准号:
9926498 - 财政年份:2019
- 资助金额:
$ 76.91万 - 项目类别:
Innovative 3D Printed Intravaginal Ring AnelleO-PRO, the first Single Administration of Progesterone for Infertility
创新 3D 打印阴道环 AnelleO-PRO,首个单次注射黄体酮治疗不孕症
- 批准号:
10760954 - 财政年份:2019
- 资助金额:
$ 76.91万 - 项目类别:
Innovative 3D Printed Intravaginal Ring AnelleO-PRO, the first Single Administration of Progesterone for Infertility
创新 3D 打印阴道环 AnelleO-PRO,首个单次注射黄体酮治疗不孕症
- 批准号:
10323463 - 财政年份:2019
- 资助金额:
$ 76.91万 - 项目类别:
Next Generation Multipurpose Intravaginal Ring Technology Using Innovative CLIP 3D Printing
采用创新 CLIP 3D 打印的下一代多用途阴道环技术
- 批准号:
10308467 - 财政年份:2019
- 资助金额:
$ 76.91万 - 项目类别:
Next Generation Multipurpose Intravaginal Ring Technology Using Innovative CLIP 3D Printing
采用创新 CLIP 3D 打印的下一代多用途阴道环技术
- 批准号:
10063935 - 财政年份:2019
- 资助金额:
$ 76.91万 - 项目类别:
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