NCT04140461

AmB Dose for Cryptococcal Meningitis

Antifungal Treatment of Cryptococcal Meningitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptococcal Meningitis
• HIV Infections

Interventions

Type	Name	Description
DRUG	Amphotericin B	The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
DRUG	Flucytosine	The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.

Timeline

• Start date: 2020-01-02
• Primary completion: 2022-03-30
• Completion: 2022-04-30
• First posted: 2019-10-25
• Last updated: 2019-10-29

Locations

1 site across 1 country: China