[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501836":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":45,"locations":56,"responsibleParty":125,"collaborators":129,"id":140,"slug":50,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":50,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":50,"enrollmentInfo":148,"targetDuration":50,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":160,"overallStatus":59,"whyStopped":50,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"Federal University of Health Science of Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single high dose arm","EXPERIMENTAL","Single high dose of liposomal amphotericin B (10 mg\u002Fkg)",[13],"Drug: Single high dose of liposomal amphotericin B",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard dose arm","ACTIVE_COMPARATOR","Standard treatment with 3 mg\u002Fkg of liposomal amphotericin B daily for 2 weeks",[19],"Drug: L-AmB standard dose",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Single high dose of liposomal amphotericin B","Single high dose (10 mg\u002Fkg) of liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS",[9],[27],"L-AmB single high dose investigational arm",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"L-AmB standard dose","Standard treatment (3 mg\u002Fkg for two weeks) with liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS",[15],[33],"L-AmB conventional therapy",[35,38,41,43],{"name":36,"affiliation":5,"role":37},"Daiane F Dalla Lana, PhD","STUDY_CHAIR",{"name":39,"affiliation":40,"role":37},"Renata B Ascenco Soares, PhD","HDT - SES\u002FGO",{"name":42,"affiliation":5,"role":37},"Luana C Genz Bazana, PhD",{"name":44,"affiliation":5,"role":37},"Tarsila Vieceli, MD MSc",[46,52],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Alessandro C Pasqualotto, MD PhD","CONTACT","+5551999951614",null,"acpasqualotto@hotmail.com",{"name":53,"role":48,"phone":54,"phoneExt":50,"email":55},"Diego R Falci, MD PhD","+5551997507835","diego.falci@gmail.com",[57,74,88,102,111],{"facility":58,"status":59,"city":60,"state":61,"zip":50,"country":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hospital de Doenças Tropicais","RECRUITING","Goiânia","Goiás","Brazil",{"type":64,"coordinates":65},"Point",[66,67],-49.25389,-16.67861,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":72,"phoneExt":50,"email":73},"Cássia Godoy","+5562996873001","cassiamirandagodoy@hotmail.com",{"facility":75,"status":59,"city":76,"state":77,"zip":50,"country":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hospital Giselda Trigueiro","Natal","Rio Grande do Norte",{"type":64,"coordinates":79},[80,81],-35.20944,-5.795,{"lat":81,"lon":80},[84],{"name":85,"role":48,"phone":86,"phoneExt":50,"email":87},"Monica Bay","+5584994141921","monibay@gmail.com",{"facility":89,"status":59,"city":90,"state":91,"zip":92,"country":62,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Federal University of Health Sciences of Porto Alegre","Porto Alegre","Rio Grande do Sul","90050-170",{"type":64,"coordinates":94},[95,96],-51.23019,-30.03283,{"lat":96,"lon":95},[99],{"name":100,"role":48,"phone":101,"phoneExt":50,"email":51},"Alessandro C. Pasqualotto, MD PhD","51999951614",{"facility":103,"status":59,"city":90,"state":91,"zip":50,"country":62,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Hospital de Clinicas de Porto Alegre",{"type":64,"coordinates":105},[95,96],{"lat":96,"lon":95},[108],{"name":109,"role":48,"phone":54,"phoneExt":50,"email":110},"Diego R Falci","dfalci@gmail.com",{"facility":112,"status":59,"city":113,"state":114,"zip":50,"country":62,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Hospital Geral de Roraima","Boa Vista","Roraima",{"type":64,"coordinates":116},[117,118],-60.67333,2.81972,{"lat":118,"lon":117},[121],{"name":122,"role":48,"phone":123,"phoneExt":50,"email":124},"Luis E Galan","+5595981218209","luis.bermejo@ufrr.br",{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Alessandro Pasqualotto","Medicine Professor, Head of Infectology",[130,133,135,138],{"name":131,"class":132},"Gilead Sciences","INDUSTRY",{"name":134,"class":6},"Financiadora de Estudos e Projetos",{"name":136,"class":137},"Sociedade Gaucha de Infectologia","UNKNOWN",{"name":139,"class":137},"Immuno-mycologics, Inc. (IMMY)","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":149,"type":150},279,"ESTIMATED","INTERVENTIONAL",[153],"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).",[156,157,158,159],"Disseminated Histoplasma Capsulatum Infection","AIDS and Infections","Immunosuppression","Fungal Infection",[161,162,163,164],"Disseminated Histoplasmosis","AIDS","Liposomal amphotericin B","Fungal infection","2025-01-31",{"date":167,"type":168},"2025-02-04","ACTUAL",{"date":170,"type":168},"2025-01-16",{"date":172,"type":150},"2026-11-28",{"name":5,"class":6},5]