Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
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.
Survival will also be evaluated by CrAg titer (comparing high titers who received Liposomal
Amphotericin B (L-AMB) to high titers who received fluconazole alone), safety, tolerability,
and cost-effectiveness of this regimen.
600 patients will be enrolled,300 in each arm.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Makerere University
Collaborators:
Gilead Sciences University of Minnesota University of Minnesota - Clinical and Translational Science Institute
Treatments:
Amphotericin B Fluconazole Liposomal amphotericin B