grant
Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (HISTO-FACT)
Organization UNIVERSITY OF MINNESOTALocation MINNEAPOLIS, UNITED STATESPosted 3 Sept 2025Deadline 31 Aug 2032
NIHUS FederalResearch GrantFY2025AIDSAIDS VirusAcquired Immune DeficiencyAcquired Immune Deficiency SyndromeAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency SyndromeAcquired Immunodeficiency Syndrome VirusAdoptedAffectAmBAmBisomeAmphocilAmphotecAmphotercin BAmphotericinAmphotericin BCardiacCase SeriesCentral AmericaCessation of lifeClinicalClinical TrialsClinical Trials DesignConsolidation TherapyDataDeathDiseaseDisease-Free SurvivalDisorderDoseDrug InteractionsDrugsElectrolytesEnrollmentEvent-Free SurvivalFungizoneGrafting ProcedureGuidelinesH capsulatumH. capsulatumHIVHealth StatusHealth systemHepatotoxic effectHepatotoxicityHistoplasma capsulatumHistoplasmosisHospital AdmissionHospitalizationHumanHuman Immunodeficiency VirusesImmuneImmunesImmunocompetentInduction TherapyInjury to KidneyItraconazoleLAV-HTLV-IIILaboratoriesLevel of HealthLiposomalLiposomesLiver ToxicityLymphadenopathy-Associated VirusM tuberculosis infectionM. tb infectionM. tuberculosis infectionM.tb infectionM.tuberculosis infectionMTB infectionMedicationModern ManMorbidityMorbidity - disease rateMusculoskeletal Pain DisorderMycobacterium tuberculosis (MTB) infectionMycobacterium tuberculosis infectionMysteclin-FNEOADJNational Institutes of HealthNeoadjuvantNeoadjuvant TherapyNeoadjuvant TreatmentObservation researchObservation studyObservational StudyObservational researchOpportunistic InfectionsOrgan TransplantationOrgan TransplantsOutcomePAHOPan American Health OrganizationParticipantPatientsPersonsPharmaceutical PreparationsPhasePhase 2 Clinical TrialsPhase II Clinical TrialsPublishingRecommendationResearch DesignResearch ResourcesResourcesRheumatic DiseasesRheumatismRheumatologic DiseasesRheumatologic DisorderSafetySerious Adverse EventSevere Adverse EventSiteSolidSouth AmericaSporanoxStudy TypeSymptomsTB infectionTestingTimeToxic effectToxic effect on liver cellsToxicitiesTranslatingTuberculosisUnited States National Institutes of HealthVirus-HIVantiretroviral therapyantiretroviral treatmentarmauthoritybudget impactclinical efficacycostdisseminated TBdisseminated tuberculosisdrug/agentenrollexperimental armhealth levelhepatic toxicityhepatoxicityimmune competentimprovedimproved outcomein vitro activityinduction therapiesinfection due to Mycobacterium tuberculosisinnovateinnovationinnovativekidney injurymortalityopen labelopen label studyorgan allograftorgan graftorgan xenograftphase 2 trialphase 3 trialphase II protocolphase II trialphase III trialposaconazoleprimary end pointprimary endpointrandomized, clinical trialsrenal injurysafety assessmentserious adverse experienceserious adverse reactionsoundstandard of carestudy designtrial comparingtuberculosis infectiontuberculous spondyloarthropathy
Description preview
Abstract
Histoplasma capsulatum causes histoplasmosis, which is estimated to occur in ~500,000 persons per year in
the U.S. alone and is most common cause of HIV-related mortality in Central and South America. While many
cases are asymptomatic or mildly symptomatic, disseminated histoplasmosis (particularly in those with immune
compromise) leads…
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