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

Launched by SHANGHAI PUBLIC HEALTH CLINICAL CENTER · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a single high dose of Liposomal Amphotericin B (L-AMB) compared to a standard treatment called Amphotericin B deoxycholate (AmBD) for patients with HIV/AIDS who have a serious fungal infection known as talaromycosis. The researchers believe that the single high dose of L-AMB will work just as well as the standard treatment but may be safer for patients. This study aims to provide evidence to support using L-AMB as a treatment option for HIV-infected individuals in China.

To participate in this trial, individuals must be at least 18 years old, newly diagnosed with HIV, and have a confirmed diagnosis of talaromycosis. Participants will receive either the high dose of L-AMB or the standard treatment (AmBD) for two weeks, followed by additional antifungal therapy. Throughout the study, researchers will monitor participants for improvements in their health, as well as any side effects they may experience. It's important for potential participants to know that this study is not yet recruiting and that specific health conditions may prevent someone from joining.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 and above
• • 2. ART naive
• • 3. HIV positive individuals
• • 4. Confirmed Talaromycosis diagnosed by culture/microscopy
• Exclusion Criteria:
• • 1. Pregnancy or lactating women;
• • 2. Central nervous system involvement (assessed either through clinical manifestations or cerebrospinal fluid analysis);
• • 3. Known allergy to AMB d/L-AMB, or the concomitant use of medications known to interact with AMB d/L-AMB;
• • 4. Alanine aminotransferase or aspartate aminotransferase levels exceeding 400 U/L;
• • 5. Absolute neutrophil count below 500/mm3;
• • 6. Creatinine clearance below 30 mL/min (calculated using the Cockcroft and Gault equation);
• • 7. Concurrent diagnosis of cryptococcal meningitis;
• • 8. Concurrent treatment with rifampicin;
• • 9. Previous treatment for talaromycosis lasting more than 48 hours.