Study of Single Dose Liposomal Amphotericin with Fluconazole to Prevent Meningitis in People with Asymptomatic Cryptococcal Antigenemia

What this Trial Is About

Researchers are evaluating the use of a single dose of liposomal amphotericin combined with fluconazole compared to fluconazole alone in people living with HIV who have asymptomatic cryptococcal antigenemia. The study aims to see if this enhanced antifungal therapy can prevent the development of cryptococcal meningitis within the first 24 weeks and improve overall survival. This is a randomized controlled trial conducted in Uganda and sponsored by Makerere University. Participants will be randomly assigned to one of two groups. One group will receive a single intravenous dose of 10 mgkg liposomal amphotericin Ambisome plus fluconazole therapy following World Health Organization guidelines for six months. The other group will receive standard care with fluconazole alone, starting with 800 mg daily for two weeks, then 400 mg for eight weeks, and finally 200 mg up to six months. The treatments are given to prevent progression to meningitis in those with positive cryptococcal antigen tests but no symptoms. During the study, participants will be monitored for the development of meningitis over 24 weeks, as well as survival rates and adverse events within two weeks of enrollment. Researchers will also assess the cost-effectiveness of the combination therapy versus fluconazole alone or no preemptive therapy. Participants will undergo regular clinic visits for treatment and assessments. The study will evaluate safety, laboratory results, and clinical outcomes to determine which approach better prevents disease progression and improves survival.

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia