Voriconazole or amphotericin B as induced drugs for the treatment of HIV-related Talaromyces marneffei infection: a multicenter, open label, randomized controlled clinical trial

Voriconazole or amphotericin B as induced drugs for the treatment of HIV-related Talaromyces marneffei infection: a multicenter, open label, randomized controlled clinical trial - A clinical trial of voriconazole in the treatment of Talaromycosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054081

Enrollment

Unknown

Registered

2021-12-08

Start date

2022-01-01

Completion date

Unknown

Last updated

2023-11-27

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

Conditions

HIV-related Talaromyces marneffei infection

Interventions

voriconazole Group:Voriconazole ivgtt q12h 14days

amphotericin B Group:amphotericin B 0.5-0.7mg/kg or Liposomes 3-5mg/kg ivgtt qd 14days

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old; 2. HIV infected; 3. Diagnosis with talaromycosis. Diagnostic criteria (with ? and any one of?, ?, ?, and ?): ? Clinical syndrome with any one of (fever, emaciation, anemia, lymph node enlargement, Liver and spleen enlargement, etc.); ? Culture positive (specimens can originate from blood, bone marrow, rash or skin secretions, lymph node tissue, alveolar lavage fluid, and other clinical tissue specimens) ? Molecular diagnosis: positive of polymerase chain reaction (qPCR); ? Antigen detection: Positive of specific MP1P antigen; ? Pathological diagnosis.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Liver dysfunction (baseline ALT and AST greater than 5 times the upper limit of normal values); 3. Severe renal insufficiency or the need for hemodialysis (creatinine clearance rate less than 30); 4. Co-infection with other systemic fungal infections (cryptococcal, candidaemia, or mucormycosis infections); 5. Diagnosed with tuberculosis and undergoing anti-tuberculosis treatment; 6. Concomitant medication has an impact on the metabolism of voriconazole (rifampicin, rifamputin, rifapentin, etc.); 7. Individuals with mental illness or abnormal behavior; 8. Receive systemic anti-fungal therapy for 48 hours or more before randomization; 9. Currently participating in other clinical trials; 10. Researchers evaluate other factors that are not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
14 days all-cause mortality;24 weeks all-cause mortality;	—

Secondary

Measure	Time frame
global clinical response;time to death;	—

Countries

China

Contacts

Public ContactCao Cunwei

The First Affiliated Hospital of Guangxi Medical University

caocunwei@yeal.com+86 139 7860 8798

Outcome results

None listed

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