drugset / Trial / NCT04140461

AmB Dose for Cryptococcal Meningitis

NCT04140461

Phase 3 Unknown 40 enrolled Shanghai Public Health Clinical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients. Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.

Timeline

Start
2020-01-02
Primary completion
2022-03-30
Completion
2022-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 0.5 mg/kg Intravenous
Subject Amphotericin B Unknown 0.7 mg/kg Intravenous
Subject Flucytosine Small molecule 100 mg/kg Oral