Platform Trial Testing New Antifungal Treatments for Cryptococcal Meningitis in Adults with HIV

What this Trial Is About

Cryptococcal meningitis is a serious fungal infection that causes severe meningitis and is fatal without antifungal treatment. This condition is especially dangerous for people living with HIV, with high mortality rates in low and middle income countries. The trial aims to evaluate multiple antifungal regimens using a master protocol with standardized eligibility, schedules, and endpoints to find better treatments with less toxicity, improved efficacy, and fewer drug interactions. Participants are randomly assigned to one of several groups standard care with liposomal amphotericin B, flucytosine, and fluconazole or one of four experimental antifungal therapies involving drugs such as oteseconazole and turletricin with various dosing schedules. Treatments include intravenous and oral medications given over several weeks, with some groups receiving combination therapies and others omitting fluconazole or flucytosine. During the study, participants will undergo lumbar punctures and regular clinic visits to monitor their condition. Researchers will measure how quickly the fungus clears from cerebrospinal fluid and monitor survival over 2 weeks, alongside other outcomes like functional status and adverse events up to 18 weeks. The trial includes thorough safety monitoring and aims to understand the effectiveness and tolerability of new antifungal regimens in people living with HIV and cryptococcal meningitis.

Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)