[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disseminated-histoplasma-capsulatum-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disseminated-histoplasma-capsulatum-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100501836","phase-3-efficacy-and-safety-of-high-dose-liposomal-amphotericin-b-for-disseminated-histoplasmosis-in-aids-100501836",false,"NCT05814432","Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS","Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg\u002Fkg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)","Inclusion Criteria:\n\n* Adult patients admitted to the centers that will be part of the study\n* Infected by the HIV, regardless of the use of antiretroviral therapy\n* Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection\n* Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection\n* Patients using fluconazole for oroesophageal candidiasis may be included\n\nExclusion criteria:\n\n* Refusal to participate in the trial\n* Previous diagnosis of histoplasmosis\n* Pregnant or lactating women\n* Patients with renal failure at any given time (serum creatinine \\> 2x or upper limit of normality (KDIGO, 2012)\n* Previous severe reaction to a polyene antifungal\n* Receipt of more than one dose of a polyene antifungal in the last 48 h\n* Suspected histoplasmosis involving the central nervous system\n* Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded\n* Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B\n* Patients with the prospect of death in the next 48 hours after selection\n* Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin\n* Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a feeding tube","ALL","18 Years",{"count":19,"type":20},279,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Phase III trial evaluating the safety and efficacy of a single high dose (10 mg\u002Fkg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg\u002Fkg of liposomal amphotericin B for two weeks) (INDUCTION trial).",[26,27,28,29],"Disseminated Histoplasma Capsulatum Infection","AIDS and Infections","Immunosuppression","Fungal Infection",[31,32,33,34],"Disseminated Histoplasmosis","AIDS","Liposomal amphotericin B","Fungal infection","RECRUITING","2025-01-31",{"date":38,"type":39},"2025-02-04","ACTUAL",{"date":41,"type":39},"2025-01-16",{"date":43,"type":20},"2026-11-28",{"name":45,"class":46},"Federal University of Health Science of Porto Alegre","OTHER",5]