Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Adjunctive Single-Dose Liposomal Amphotericin to Prevent Cryptococcal Meningitis in People With HIV-Associated Cryptococcal Antigenemia and Low Plasma Cryptococcal Antigen Titers.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03945448 (Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons), which is not on this map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
Who cites it
8 citing papers in PubMed.
- Trial
- Rethinking Routine Lumbar Puncture and Induction Therapy in Non-HIV Pulmonary Cryptococcosis: A Call for Risk-Based Management.Mycopathologia · 2026Article
- Clinical spectrum, immune status, and prognostic factors of cryptococcosis: insights from a large, multi-center, ambispective cohort study in southeastern China.Infectious diseases of poverty · 2026Article
- Ten years on: Ongoing challenges in screening for cryptococcal antigenaemia in people with advanced HIV disease in South Africa.Southern African journal of HIV medicine · 2026Article
- Article
- Effectiveness of a National Reflex Laboratory Cryptococcal Antigen Screening Program for People With Advanced HIV Disease in South Africa: A Nationwide-Sampled Cohort Study (CAST-NET).Journal of acquired immune deficiency syndromes (1999) · 2025Article
- Can liposomal amphotericin B be used as a preventive measure for cryptococcal meningitis?Expert review of anti-infective therapy · 2025Article
- Update on neurological complications of HIV.Current opinion in HIV and AIDS · 2025Review
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundCryptococcal meningitis is a leading cause of AIDS-related mortality. Cryptococcal antigen (CrAg) predicts the development of meningitis. Historically, despite standard- of-care fluconazole, 25%-30% of asymptomatic CrAg-positive persons develop breakthrough meningitis or death. We evaluated whether adding single high-dose liposomal amphotericin B to standard pre-emptive fluconazole therapy could improve meningitis-free survival.
methodsParticipants with human immunodeficiency virus (HIV) and asymptomatic cryptococcal antigenemia in Uganda were randomized to liposomal amphotericin B (10 mg/kg once) with fluconazole or fluconazole alone through 24 weeks. We compared 24-week, meningitis-free survival time between treatment groups. After the second interim review, the Data Safety and Monitoring Board recommended no further enrollment of participants with low plasma CrAg lateral flow assay titers (≤1:80) due to futility. Herein, we present the results of participants with low plasma CrAg titers.
results168 participants enrolled into the ACACIA trial had low plasma CrAg titers (≤1:80). During 24 weeks of follow-up, meningitis or death occurred in 14.5% (12/83) of participants randomized to liposomal amphotericin B with fluconazole versus 10.6% (9/85) assigned to fluconazole alone (hazard ratio, 1.42; 95% CI, .60-3.36; P = .431). Adverse events were more frequent in participants assigned to the intervention versus standard-of-care (28% vs 12%; P = .011).
conclusionsAmong CrAg-positive persons with low titers (≤1:80), the addition of single-dose liposomal amphotericin B to fluconazole as pre-emptive therapy provided no additional clinical benefit. This trial provides supportive evidence that, in asymptomatic populations with low plasma CrAg titers, lumbar punctures are likely unnecessary as administration of meningitis treatment did not improve outcomes. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov (NCT03945448).
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