Clinical Trial

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Study acronym: ACACIA
Recruiting Phase 2/3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-05-08; most recent amendment 2026-04-27.
Status change: Not Yet Recruiting → Recruiting 2020-02-06
Trial Details
NCT Number NCT03945448
Lead Sponsor Makerere University
Collaborators: University of Minnesota, Gilead Sciences
Conditions Cryptococcal Meningitis
Enrollment 356 participants
Start Date 2019-06-20
Primary Completion 2027-06 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-28