drugset / Trial / NCT03945448

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

NCT03945448

RandomizedParallel-groupOpen-labelPrevention

Summary

This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda. Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy. How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.

Timeline

Start
2019-06-20
Primary completion
2027-06
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Amphotericin B Unknown 10 mg/kg Intravenous
Comparator Fluconazole Small molecule 200 mg