Single high-dose liposomal amphotericin B plus B/F/TAF for AIDS-associated talaromycosis in China: a multicentre randomised controlled trial protocol.

Abstract

Talaromycosis is a severe fungal infection caused by <i>Talaromyces marneffei</i> that predominantly affects people living with HIV (PLWH), particularly in southern China where it contributes substantially to AIDS-related mortality. While liposomal amphotericin B (L-AMB) is preferred for induction therapy due to its superior safety profile over conventional amphotericin B deoxycholate (AmBD), the efficacy of a single high-dose L-AMB regimen in talaromycosis remains unestablished. Furthermore, current guidelines recommend initiating antiretroviral therapy (ART) within 1 week of antifungal treatment, though real-world evidence in Chinese populations is limited. This study aims to evaluate the efficacy and safety of single high-dose L-AMB for AIDS-associated talaromycosis and provide clinical evidence on early initiation of bictegravir/emtricitabine/tenofovir alafenamide fumarate (B/F/TAF) in this population. This multicentre, randomised controlled phase II clinical trial compares the efficacy and safety of single high-dose L-AMB (10 mg/kg), followed by itraconazole capsule 200 mg every 12 hours for the remaining 13 days of induction therapy, versus AmBD (0.5 mg/kg/day for 14 days) as induction therapy for AIDS-associated talaromycosis in PLWH adults with microbiologically confirmed diagnosis. Eligible participants (n=116) will be randomly assigned (1:1) at four Chinese centres to receive either treatment, followed by 10 weeks of itraconazole capsule consolidation therapy and secondary prophylaxis until CD4+ T-lymphocyte counts exceed 100 cells/mm³ for ≥6 months, with ART initiated within 7 days of antifungal treatment according to current ART guidelines. The primary endpoint is clinical resolution rate after induction, while secondary endpoints include overall survival, organ function recovery and adverse event incidence. This study was approved by the Institutional Review Board of Shanghai Public Health Clinical Centre (Approval No. 2025-S039-01) and the ethics committees of all participating study centres: Guiyang Public Health Treatment Centre, Mengchao Hepatobiliary Hospital of Fujian Medical University and Chest Hospital of Guangxi Zhuang Autonomous Region. All procedures were conducted in accordance with the ethical standards of the Declaration of Helsinki and national regulations. Written informed consent was obtained from all participants prior to enrolment. The findings of this study will be disseminated through publications in international peer-reviewed journals and presentations at scientific conferences. Participants who express interest in the study results will be provided with a summary report following the release of the primary findings. ClinicalTrials. gov NCT06926569.