Skip to content

Single high-dose of liposomal amphotericin B in combination with B/F/TAF for HIV/AIDS-associated talaromycosis: a randomized controlled trial

Single high-dose of liposomal amphotericin B in combination with B/F/TAF for HIV/AIDS-associated talaromycosis: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104437
Enrollment
Unknown
Registered
2025-06-17
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-associated talaromycosis

Interventions

single high-dose L-AmB group:single high-dose L-AmB
control group:amphotericin B deoxycholate(AmBD)

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 and above; 2.ART naïve; 3.HIV positive individuals; 4.Confirmed Talaromycosis diagnosed by culture/microscopy;

Exclusion criteria

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 hour;

Design outcomes

Primary

MeasureTime frame
the proportion of participants who achieve clinical resolution on day 14;

Secondary

MeasureTime frame
Time to achieve a sterile blood culture;overall survival;time to clinical remission;

Countries

China

Contacts

Public Contactshenyinzhong

Shanghai Public Health Clinical Center

shenyinzhong@shphc.org.cn+86 21 37990333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026