[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587298":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":25,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":25,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Shanghai Public Health Clinical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single high-dose L-AmB group","EXPERIMENTAL","After enrollment, participants will be 1:1 randomly assigned into two groups for induction therapy after informed consent: single high-dose L-AmB group (10 mg\u002Fkg single intravenous dose of L-AMB) and control group (amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg\u002Fkg\u002Fd intravenously for 14 days as the standard of care recommended by local guidelines).Thereafter, all participants in both groups will start consolidation therapy within 24 hours of the induction treatment, 200mg itraconazole(or voriconazole) q12h will be given for 10 weeks. After consolidation therapy, all participants will take oral itraconazole 200mg qd as secondary prophylaxis until their CD4+ cell counts are higher than 100cells\u002Fmm3 for at least 6 months. For the antiretroviral therapy, all participants will start B\u002FF\u002FTAF qd within 7 days after initiating antifungal therapy.",[13],"Drug: AmBisome",{"label":15,"type":16,"description":11,"interventionNames":17},"Control group","OTHER",[18],"Drug: Amphotericin B",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Amphotericin B","After enrollment, participants will be 1:1 randomly assigned into two groups for induction therapy after informed consent: single high-dose L-AmB group (10 mg\u002Fkg single intravenous dose of L-AMB) and control group (amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg\u002Fkg\u002Fd intravenously for 14 days as the standard of care recommended by local guidelines).Thereafter, all participants in both groups will start consolidation therapy within 24 hours of the induction treatment, 200mg itraconazole(or voriconazole) q12h will be given for 10 weeks. After consolidation therapy, all participants will take oral itraconazole 200mg qd as secondary prophylaxis until their CD4+ cell counts are higher than 100cells\u002Fmm3 for at least 6 months. For the antiretroviral therapy, all participants will start B\u002FF\u002FTAF qd within 7 days after initiating antifungal therapy",[15],null,{"type":21,"name":27,"description":11,"armGroupLabels":28,"otherNames":25},"AmBisome",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Shen Yinzhong Dr.","CONTACT","+8618916113951","shenyinzhong@shphc.org.cn",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Yinzhong Shen","Principal Investigator","100587298","single-high-dose-of-liposomal-amphotericin-b-in-combination-with-bftaf-for-hivaids-associated-talaromycosis-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":48,"type":49},116,"ESTIMATED","INTERVENTIONAL",[52],"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.",[55],"HIV\u002FAIDS-associated Talaromycosis",[57],"HIV\u002FAIDS-associated talaromycosis","NOT_YET_RECRUITING","2025-04-07",{"date":61,"type":62},"2025-04-13","ACTUAL",{"date":64,"type":49},"2025-05-01",{"date":66,"type":49},"2026-05-01",{"name":5,"class":6}]