[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501836":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":45,"locations":56,"responsibleParty":126,"collaborators":130,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":50,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":50,"enrollmentInfo":150,"targetDuration":50,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":162,"overallStatus":59,"whyStopped":50,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"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",[57,75,89,103,112],{"facility":58,"status":59,"city":60,"state":61,"zip":50,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Hospital de Doenças Tropicais","RECRUITING","Goiânia","Goiás","Brazil","BR",{"type":65,"coordinates":66},"Point",[67,68],-49.25389,-16.67861,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":73,"phoneExt":50,"email":74},"Cássia Godoy","+5562996873001","cassiamirandagodoy@hotmail.com",{"facility":76,"status":59,"city":77,"state":78,"zip":50,"country":62,"countryCode":63,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Hospital Giselda Trigueiro","Natal","Rio Grande do Norte",{"type":65,"coordinates":80},[81,82],-35.20944,-5.795,{"lat":82,"lon":81},[85],{"name":86,"role":48,"phone":87,"phoneExt":50,"email":88},"Monica Bay","+5584994141921","monibay@gmail.com",{"facility":90,"status":59,"city":91,"state":92,"zip":93,"country":62,"countryCode":63,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Federal University of Health Sciences of Porto Alegre","Porto Alegre","Rio Grande do Sul","90050-170",{"type":65,"coordinates":95},[96,97],-51.23019,-30.03283,{"lat":97,"lon":96},[100],{"name":101,"role":48,"phone":102,"phoneExt":50,"email":51},"Alessandro C. Pasqualotto, MD PhD","51999951614",{"facility":104,"status":59,"city":91,"state":92,"zip":50,"country":62,"countryCode":63,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Hospital de Clinicas de Porto Alegre",{"type":65,"coordinates":106},[96,97],{"lat":97,"lon":96},[109],{"name":110,"role":48,"phone":54,"phoneExt":50,"email":111},"Diego R Falci","dfalci@gmail.com",{"facility":113,"status":59,"city":114,"state":115,"zip":50,"country":62,"countryCode":63,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Hospital Geral de Roraima","Boa Vista","Roraima",{"type":65,"coordinates":117},[118,119],-60.67333,2.81972,{"lat":119,"lon":118},[122],{"name":123,"role":48,"phone":124,"phoneExt":50,"email":125},"Luis E Galan","+5595981218209","luis.bermejo@ufrr.br",{"type":127,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Alessandro Pasqualotto","Medicine Professor, Head of Infectology",[131,134,136,139],{"name":132,"class":133},"Gilead Sciences","INDUSTRY",{"name":135,"class":6},"Financiadora de Estudos e Projetos",{"name":137,"class":138},"Sociedade Gaucha de Infectologia","UNKNOWN",{"name":140,"class":138},"Immuno-mycologics, Inc. (IMMY)","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":151,"type":152},279,"ESTIMATED","INTERVENTIONAL",[155],"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).",[158,159,160,161],"Disseminated Histoplasma Capsulatum Infection","AIDS and Infections","Immunosuppression","Fungal Infection",[163,164,165,166],"Disseminated Histoplasmosis","AIDS","Liposomal amphotericin B","Fungal infection","2025-01-31",{"date":169,"type":170},"2025-02-04","ACTUAL",{"date":172,"type":170},"2025-01-16",{"date":174,"type":152},"2026-11-28",{"name":5,"class":6},5]