Long-Acting Prevention Implantable System (LAPIS) for HIV Pre-ExposureProphylaxis (PrEP)
用于 HIV 暴露前预防 (PrEP) 的长效预防植入系统 (LAPIS)
基本信息
- 批准号:10581520
- 负责人:
- 金额:$ 66.25万
- 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:2020-03-06 至 2025-02-28
- 项目状态:未结题
- 来源:
- 关键词:2&apos-deoxyadenosineAchievementAddressAdherenceAdultAdverse reactionsAnti-Retroviral AgentsAntiretroviral resistanceBehavioral ResearchBiodegradationBypassCenters for Disease Control and Prevention (U.S.)CharacteristicsDevicesDoseDrug Delivery SystemsDrug KineticsEffectivenessEvaluationExcisionFormulationGoalsHIVHIV InfectionsHIV antiretroviralHIV resistanceHeterosexualsImplantIn VitroIncidenceInternationalInterventionKineticsLeadMacaca mulattaModelingMutationNew ZealandNorth CarolinaNucleosidesOralOryctolagus cuniculusPatternPharmaceutical PreparationsPharmacologic SubstancePolymersPopulationPreventionProdrugsPropertyResearchResearch InstituteReverse Transcriptase InhibitorsRouteSafetyScienceSocial BehaviorSpecific qualifier valueSystemTailTechnologyTenofovirTestingTherapeuticUniversitiesVirus DiseasesWorkbreakthrough infectioncis-femaleclinical translationcombatdrug release kineticsdrug release profiledrug resistant virusforgettingimplant designin vivoinnovationlow and middle-income countriesmanufacturing processmechanical propertiesmenmen who have sex with menmultidisciplinarymutantnonhuman primatenovelpenispre-exposure prophylaxispreclinical studypreferencepreventproduct developmentprogramsprophylacticprototyperesearch and developmentsafety assessmentscale upsimian human immunodeficiency virussubcutaneoustransgender womentransmission processviral transmissionyoung manyoung woman
项目摘要
PROJECT SUMMARY
The long-term goal of this proposed project is to deliver an innovative, end-user-informed HIV pre-exposure
prophylaxis (PrEP) product in the form of a Long-Acting Prevention Implantable System (LAPIS). LAPIS offers
a combination of attributes that surpass existing delivery systems for PrEP and align with young men and
women's preferences: user independence, discretion, long-term protection (1 year), as well as favorable zero-
order release kinetics of drugs, reversibility over the therapeutic window, delivery of multiple antiretrovirals
(ARVs), and bioerosion of the spent implant to bypass obligatory removal. The implant is uniquely retrievable,
if needed, for the duration of drug delivery, but otherwise remains stationary and biodegrades after depletion of
the drug. In this manner, reversal of drug delivery is possible in the case of adverse reactions or a user's desire
for discontinuation. The implant technology also decouples drug delivery characteristics from biodegradation
properties and can achieve zero-order kinetics of drug release. The LAPIS platform can accommodate different
classes of active pharmaceutical ingredients (APIs) and also enables the delivery of combination ARVs for
PrEP, thereby addressing the potential for increased efficacy (as demonstrated for oral dosing) and providing a
higher barrier for ARV-resistant HIV strains. The proposed specific aims are: (1) To develop an implant system
for delivery of ARVs for HIV PrEP, subcutaneously inserted and lasting 1 year to support adherence, safety,
and effectiveness; (2) To evaluate safety, pharmacokinetics (PK), and in vivo drug depletion profiles of LAPIS
in preclinical studies; and (3) To test the prophylactic efficacy of LAPIS in preventing wild-type and ARV-
resistant simian-human immunodeficiency virus (SHIV) transmission via the penile route within nonhuman
primates (NHPs). Importantly, the proposed work will leverage achievements made during earlier programs in
developing the implant platform and will build upon this work in the following key aspects: long-term active
pharmaceutical ingredient (API) delivery (up to 1 year), delivery of dual APIs, characterization of drug depletion
profiles, and evaluation of prophylactic efficacy in NHPs. Our established and complementary team will use a
Research Strategy that is milestone-driven, with clear expected deliverables guiding progress of product
development and clinical translation.
项目总结
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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Leah Johnson其他文献
Leah Johnson的其他文献
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{{ truncateString('Leah Johnson', 18)}}的其他基金
Long-Acting Prevention Implantable System (LAPIS) for HIV Pre-ExposureProphylaxis (PrEP)
用于 HIV 暴露前预防 (PrEP) 的长效预防植入系统 (LAPIS)
- 批准号:
10348177 - 财政年份:2020
- 资助金额:
$ 66.25万 - 项目类别:
Acceptable Multi-user Biodegradable Extended Release (AMBER) Implant System for HIV Prevention
用于预防艾滋病毒的可接受的多用户可生物降解缓释 (AMBER) 植入系统
- 批准号:
10450884 - 财政年份:2020
- 资助金额:
$ 66.25万 - 项目类别:
Long-Acting Prevention Implantable System (LAPIS) for HIV Pre-Exposure Prophylaxis (PrEP)
用于 HIV 暴露前预防 (PrEP) 的长效预防植入系统 (LAPIS)
- 批准号:
10010563 - 财政年份:2020
- 资助金额:
$ 66.25万 - 项目类别:
Acceptable Multi-user Biodegradable Extended Release (AMBER) Implant System for HIV Prevention
用于预防艾滋病毒的可接受的多用户可生物降解缓释 (AMBER) 植入系统
- 批准号:
10242929 - 财政年份:2020
- 资助金额:
$ 66.25万 - 项目类别:
Acceptable Multi-user Biodegradable Extended Release (AMBER) Implant System for HIV Prevention
用于预防艾滋病毒的可接受的多用户可生物降解缓释 (AMBER) 植入系统
- 批准号:
10663830 - 财政年份:2020
- 资助金额:
$ 66.25万 - 项目类别:
Acceptable Multi-user Biodegradable Extended Release (AMBER) Implant System for HIV Prevention
用于预防艾滋病毒的可接受的多用户可生物降解缓释 (AMBER) 植入系统
- 批准号:
10064253 - 财政年份:2020
- 资助金额:
$ 66.25万 - 项目类别:
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