Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

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

Outcome

Missed primary endpoint

paper hazard ratio, 1.42; 95% CI, .60-3.36; P = .431 PMID 39044381 ↗

paper the addition of single-dose liposomal amphotericin B to fluconazole as pre-emptive therapy provided no additional clinical benefit. PMID 39044381 ↗

Publications

• Meya DB, Nalintya E, Skipper CP, Kirumira P, Ayebare P, Naluyima R, Namuli T, Turya F, Walukaga S, Engen N, Hullsiek KH, Wele A, Dai B, Boulware DR, Rajasingham R. Adjunctive Single-Dose Liposomal Amphotericin to Prevent Cryptococcal Meningitis in People With HIV-Associated Cryptococcal Antigenemia and Low Plasma Cryptococcal Antigen Titers. Clin Infect Dis. 2025 Feb 5;80(1):129-136. doi: 10.1093/cid/ciae266.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amphotericin B	Unknown	10 mg/kg	Intravenous
Comparator	Fluconazole	Small molecule	200 mg	—

Indications