Platform Trial For Cryptococcal Meningitis Evaluating Multiple Antifungal Treatments in Adults Living With HIV

What this Trial Is About

Cryptococcal meningitis is a serious fungal infection that is fatal without antifungal treatment. This condition is particularly dangerous for people living with HIV, especially in low and middle income countries where mortality remains high despite treatment. Current main treatments include amphotericin and flucytosine, but challenges like limited drug availability, toxicity, and increasing fungal resistance highlight the need for new antifungal medicines. This trial uses a master protocol to study multiple antifungal regimens with standardized eligibility and outcome measures. Participants will be randomly assigned to one of several study groups, including standard care or one of four experimental antifungal therapies. Standard care involves liposomal amphotericin B, flucytosine, and fluconazole given over several weeks. Experimental treatments include oral oteseconazole with a single dose of amphotericin, SF001 injections combined with fluconazole and flucytosine, and two other antifungal therapies yet to be determined. Treatment schedules and dosages vary by regimen. Throughout the study, participants will be monitored for fungal clearance from cerebrospinal fluid, survival rates, and functional status over periods ranging from 2 to 18 weeks. Researchers will assess safety through lab tests and adverse event tracking, as well as the need for additional treatment. Participants will undergo lumbar punctures as specified and will be regularly evaluated to measure treatment effects and side effects. The trial aims to improve antifungal therapy options and outcomes for cryptococcal meningitis in people with HIV.

Platform Trial For Cryptococcal Meningitis