Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis

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. The investigators hypothesize that L-AMB induction therapy (10 mg/kg) is non-inferior to AmBD (0.5-0.7 mg/kg/d) in efficacy and has an improved safety profile. The 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. Study 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. Interventions: 1. L-AMB group receives a single intravenous dose of 10 mg/kg L-AMB. 2. Control group receives intravenous AmBD at 0.5-0.7 mg/kg/d for 14 days. 3. Both groups start consolidation therapy with itraconazole 200mg q12h for 10 weeks within 24 hours post-induction. 4. Secondary prophylaxis with itraconazole 200mg qd until CD4+ cell counts exceed 100cells/mm³ for at least 6 months. 5. All start B/F/TAF qd within 7 days post-antifungal therapy. Primary Objective： This multicenter study compares efficacy/safety 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. Secondary Objectives： Evaluate feasibility/safety of initiating B/F/TAF within 7 days post-antifungal therapy, providing evidence for rapid ART guidelines in these patients. Endpoints: * Primary: Proportion achieving clinical resolution on day 14. * 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. Sample Size: 58 participants per group (116 total), considering a 10% dropout rate.

NCT Number	NCT06926569
Lead Sponsor	Shanghai Public Health Clinical Center
Conditions	HIV/AIDS-associated Talaromycosis
Enrollment	116 participants
Start Date	2025-05-01
Primary Completion	2026-01-05 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-13