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.
Aged 18 and above
ART naive
HIV positive individuals
Confirmed Talaromycosis diagnosed by culture/microscopy
Pregnancy or lactating women;
Central nervous system involvement (assessed either through clinical manifestations or cerebrospinal fluid analysis);
Known allergy to AMB d/L-AMB, or the concomitant use of medications known to interact with AMB d/L-AMB;
Alanine aminotransferase or aspartate aminotransferase levels exceeding 400 U/L;
Parallel
Amphotericin B
DrugAfter 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/kg single intravenous dose of L-AMB) and control group (amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg/kg/d 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/mm3 for at least 6 months. For the antiretroviral therapy, all participants will start B/F/TAF qd within 7 days after initiating antifungal therapy
AmBisome
DrugAfter 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/kg single intravenous dose of L-AMB) and control group (amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg/kg/d 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/mm3 for at least 6 months. For the antiretroviral therapy, all participants will start B/F/TAF qd within 7 days after initiating antifungal therapy.
the proportion of participants who achieve clinical resolution on day 14
The primary endpoint is the proportion of participants who achieve clinical resolution on day 14 . Clinical resolution defined as resolution of symptoms/signs attributable to talaromycosis, such as fever and rash (temperature below 38 for more than 3 days, improvement of rash) and sterile blood cultures, except for manifestations that are expected to last for more than 14 days after treatment initiation: hepatosplenomegaly, jaundice and pancytopenia.
Overall Survival
overall survival one day14
Adverse Events
renal function abnormalities, anemia, and liver function abnormalities and clinical or laboratory-defined adverse events of grade 3 or higher on d14.
The Time to Clinical Resolution
defined as resolution of symptoms/signs attributable to talaromycosis, such as fever and rash (temperature below 38 for more than 3 days, improvement of rash) and sterile blood cultures, except for manifestations that are expected to last for more than 14 days after treatment initiation
The Time to Achieve Sterile Blood Cultures
the rate of fungal clearance from blood at 7 and14 days over the course of induction therapy
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