grant
Ultra-long-acting in-situ forming implant (ISFI) as a subcutaneous injection for prevention of HIV and unplanned pregnancy
Organization UNIV OF NORTH CAROLINA CHAPEL HILLLocation CHAPEL HILL, UNITED STATESPosted 14 Apr 2026Deadline 31 Mar 2028
NIHUS FederalResearch GrantFY2026AIDS VirusAIDS preventionAbscissionAccelerated PhaseAccelerationAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusAddressAdverse ExperienceAdverse eventAfricaAfricanAgreementAnimalsAnti-Retroviral AgentsBALB C MouseBALB/cCharacteristicsClinicalClinical ResearchClinical StudyCommon Rat StrainsContraceptionContraceptive AgentsContraceptive UsageContraceptive methodsContraceptivesContracting OpportunitiesContractsCopper Intrauterine DevicesCopper Releasing IUDCorlutinaCorluviteCorpus Luteum HormoneCountryCyclogestDataDelta4-pregnene-3,20-dioneDepo-Medroxyprogesterone AcetateDevelopmentDoseDrug DeliveryDrug Delivery SystemsDrug KineticsDrugsEngineeringEpidemicEvaluationEventExcipientsExcisionExtirpationFDA approvedFatigueFemaleFertility ControlFormulationGestagenic AgentsGestagensGestationGestironGestoneGoalsGrantHIVHIV InfectionsHIV PreventionHIV disease transmissionHIV incidenceHIV infection spreadHIV infection transmissionHIV spreadHIV transmissionHIV viral infectionHIV viral transmissionHIV virus infectionHIV-1 incidenceHIV-1 infectionHIV-1 infection incidenceHIV-1 preventionHIV-1 spreadHIV-1 transmissionHIV-1 virus transmissionHIV/AIDS incidenceHIV/AIDS preventionHIV/AIDS transmissionHealth BenefitHealth protectionHumanHuman Immunodeficiency Virus Type 1 transmissionHuman Immunodeficiency VirusesIND FilingIND applicationIND packageIND submissionImplantImplantable Drug Delivery SystemsImplantable Infusion PumpsImplantable Perfusion PumpsIn SituIn VitroInbred BALB C MiceIncidenceInfection by HIV-1Infection from HIV-1Infection of HIV-1Inhibition of FertilizationInjectableInjectionsIntramuscular InjectionsInvestigational New Drug ApplicationInvestigatorsLAV-HTLV-IIILack of EnergyLipo-LutinLiquid substanceLuteohormoneLutocyclinLutocylin MLutogylLutromoneLymphadenopathy-Associated VirusMacacaMacaqueMedicationMedroxyprogesterone 17-AcetateMedroxyprogesterone AcetateMedroxyprogesteroni AcetasMethodsMethylacetoxyprogesteroneMetipregnoneMiceMice MammalsModelingModern ManMultipurpose prevention technologyMurineMusNHP modelsOvulationPK/PDPatientsPerformancePharmaceutical PreparationsPharmacokineticsPhasePhase 3 Clinical TrialsPhase III Clinical TrialsPost-vaccination infectionPrEPPre IND FDA meetingPre-IND mtgPregn-4-ene-3,20-dionePregnancyPregnenedionePreparationPrevent HIVPrivacyProcessProgestagenic AgentsProgestasertProgestational AgentsProgestational CompoundsProgestational HormonesProgesteroneProgesterone AgentsProgestinsProgestogelProgestogensProgestolProgestonProlidonProlutonPropertyProphylactic treatmentProphylaxisPublic HealthRatRats MammalsRattusRegimenRemovalResearch PersonnelResearchersResidualResidual stateRodentRodentiaRodents MammalsSHIVSafetyScienceSexual TransmissionSexually Transmitted DiseasesSexually Transmitted DisorderSexually Transmitted InfectionSiteSubcutaneous InjectionsSurgical RemovalSuspension substanceSuspensionsSyngesteroneSystemTailTechnologyTechnology TransferTherapeutic ProgesteroneTherapeutic ProgestinTimeToxic effectToxicitiesTranslationsTrocarsUnplanned pregnancyUser ComplianceUtrogestanVaginal RingVenereal DiseasesVenereal DisordersVenereal InfectionsViralVirus-HIVWomanWritingallergen responseallergic responseallergy responseanti-retroviralbiomedical implantbreakthrough infectionclinical translationclinically translatablecommercial scale manufacturingcomparativecompound optimizationcontraceptive usecontrolled releasecopper IUDcopper intra-uterine contraceptivecopper intra-uterine devicecopper intrauterine contraceptivecost effectivedesigndesigningdevelopmentaldrug/agentfluidformulation optimizationglobal healthhigh riskhuman immunodeficiency virus incidencehuman immunodeficiency virus infectionhuman immunodeficiency virus transmissionimplant designimplant deviceimplantable devicein vivoindwelling deviceinfected with HIVinfected with human immunodeficiency virusinnovateinnovationinnovativeintramuscular drug administrationintravaginal ringlead optimizationliquidmanufacturemanufacturing ramp-upmanufacturing scale-upmeetingmeetingsmenmultipurpose preventionnano particlenano-sized particlenanoparticlenanosized particlenew drug treatmentsnew drugsnew pharmacological therapeuticnew therapeuticsnew therapynext generation therapeuticsnonhuman primate modelsnovelnovel drug treatmentsnovel drugsnovel pharmaco-therapeuticnovel pharmacological therapeuticnovel therapeuticsnovel therapyparticlepathogenpharmacokinetic modelpharmacokinetics and pharmacodynamicspharmacometricsphase III protocolpillpre-IND consultationpre-IND discussionpre-IND meetingpre-Investigational New Drug meetingpre-clinicalpre-exposure prophylaxispreclinicalpreparationsprevent AIDSprevent human immunodeficiency virusprophylacticrational designresectionscale up batchscale up productionsexsexually acquired infectionsexually transmittedsimian HIVsimian human immunodeficiency virusspread of human immunodeficiency virussubdermal injectiontranslationunintended pregnancyupscale manufacturing♀
Description preview
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. Long-acting (LA) formulations that provide…
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