[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hivaids-associated-talaromycosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hivaids-associated-talaromycosis":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":15,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100587298",false,"NCT06926569","Single High-dose of Liposomal Amphotericin B in Combination With B\u002FF\u002FTAF for HIV\u002FAIDS-associated Talaromycosis","Inclusion Criteria:\n\n1. Aged 18 and above\n2. ART naive\n3. HIV positive individuals\n4. Confirmed Talaromycosis diagnosed by culture\u002Fmicroscopy\n\nExclusion Criteria:\n\n1. Pregnancy or lactating women;\n2. Central nervous system involvement (assessed either through clinical manifestations or cerebrospinal fluid analysis);\n3. Known allergy to AMB d\u002FL-AMB, or the concomitant use of medications known to interact with AMB d\u002FL-AMB;\n4. Alanine aminotransferase or aspartate aminotransferase levels exceeding 400 U\u002FL;\n5. Absolute neutrophil count below 500\u002Fmm3;\n6. Creatinine clearance below 30 mL\u002Fmin (calculated using the Cockcroft and Gault equation);\n7. Concurrent diagnosis of cryptococcal meningitis;\n8. Concurrent treatment with rifampicin;\n9. Previous treatment for talaromycosis lasting more than 48 hours.","ALL","18 Years",{"count":17,"type":18},116,"ESTIMATED","INTERVENTIONAL",[21],"NA","This study aims to compare the efficacy and safety of a single high-dose Liposomal Amphotericin B (L-AMB) against conventional Amphotericin B deoxycholate (AmBD) for HIV-associated Talaromycosis.\n\nThe investigators hypothesize that L-AMB induction therapy (10 mg\u002Fkg) is non-inferior to AmBD (0.5-0.7 mg\u002Fkg\u002Fd) in efficacy and has an improved safety profile.\n\nThe study's primary objective is to provide evidence supporting the guideline recommendation of single high-dose L-AMB for HIV-infected individuals with talaromycosis, while validating L-AMB's efficacy and safety in China.\n\nStudy Design: Multi-center, randomized controlled trial comparing single high-dose L-AMB to guideline-recommended AmBD induction therapy for HIV-associated talaromycosis. Participants are HIV-infected adults (≥18 years) with confirmed talaromycosis by microscopy or culture.\n\nInterventions:\n\n1. L-AMB group receives a single intravenous dose of 10 mg\u002Fkg L-AMB.\n2. Control group receives intravenous AmBD at 0.5-0.7 mg\u002Fkg\u002Fd for 14 days.\n3. Both groups start consolidation therapy with itraconazole 200mg q12h for 10 weeks within 24 hours post-induction.\n4. Secondary prophylaxis with itraconazole 200mg qd until CD4+ cell counts exceed 100cells\u002Fmm³ for at least 6 months.\n5. All start B\u002FF\u002FTAF qd within 7 days post-antifungal therapy.\n\nPrimary Objective： This multicenter study compares efficacy\u002Fsafety of single high-dose L-AMB vs standard AmBD (2-week) induction for HIV-associated talaromycosis, generating evidence to support L-AMB guidelines in Chinese populations.\n\nSecondary Objectives： Evaluate feasibility\u002Fsafety of initiating B\u002FF\u002FTAF within 7 days post-antifungal therapy, providing evidence for rapid ART guidelines in these patients.\n\nEndpoints:\n\n* Primary: Proportion achieving clinical resolution on day 14.\n* Secondary: Overall survival, renal function, anemia, liver function, adverse events grade 3 or higher on day 14; time to clinical resolution and sterile blood cultures; survival, HIV viral suppression, CD4+ T-cell counts, adverse events (including IRIS), ART persistency, and patient-reported outcomes at weeks 4, 12, and 24.\n\nSample Size: 58 participants per group (116 total), considering a 10% dropout rate.",[24],"HIV\u002FAIDS-associated Talaromycosis",[26],"HIV\u002FAIDS-associated talaromycosis","NOT_YET_RECRUITING","2025-04-07",{"date":30,"type":31},"2025-04-13","ACTUAL",{"date":33,"type":18},"2025-05-01",{"date":35,"type":18},"2026-05-01",{"name":37,"class":38},"Shanghai Public Health Clinical Center","OTHER_GOV",""]