Status:
NOT_YET_RECRUITING
Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis
Lead Sponsor:
Shanghai Public Health Clinical Center
Conditions:
HIV/AIDS-associated Talaromycosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Scientific Basis/Rationale Talaromycosis caused by Talaromyces marneffei (TM) is a highly aggressive fungal infection predominantly observed in people living with HIV (PLWH). The mortality rate for un...
Eligibility Criteria
Inclusion
- Aged 18 and above
- ART naive
- HIV positive individuals
- Confirmed Talaromycosis diagnosed by culture/microscopy
Exclusion
- 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;
- Absolute neutrophil count below 500/mm3;
- Creatinine clearance below 30 mL/min (calculated using the Cockcroft and Gault equation);
- Concurrent diagnosis of cryptococcal meningitis;
- Concurrent treatment with rifampicin;
- Previous treatment for talaromycosis lasting more than 48 hours.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06926569
Start Date
May 1 2025
End Date
May 1 2026
Last Update
April 13 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.