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NCT06926569Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
116 (estimated)
First submitted
21 Mar 2025
Start date
1 May 2025
Primary completion date
5 Jan 2026
Lead sponsor
Shanghai Public Health Clinical Center
Diseases
HIV
NCT number
NCT06926569

What you commit to

  • Study type: Interventional
  • Planned participants: 116
  • From 1 May 2025 to the primary completion date, 5 Jan 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known allergy to AMB d/L-AMB, or the concomitant use of medications known to interact with AMB d/L-AMB;
  • Concurrent diagnosis of cryptococcal meningitis;
  • Concurrent treatment with rifampicin;
  • Previous treatment for talaromycosis lasting more than 48 hours.

Lab values

  • Absolute neutrophil count below 500/mm3;
  • Creatinine clearance below 30 mL/min (calculated using the Cockcroft and Gault equation);

Other

  • Pregnancy or lactating women;
  • Central nervous system involvement (assessed either through clinical manifestations or cerebrospinal fluid analysis);
  • Alanine aminotransferase or aspartate aminotransferase levels exceeding 400 U/L;

Who the study is looking for

  • Aged 18 and above
  • ART naive
  • HIV positive individuals
  • Confirmed Talaromycosis diagnosed by culture/microscopy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.