NCT06666322 Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
| NCT ID | NCT06666322 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Minnesota |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2032-04-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 2,000 participants in total. It began in 2025-05-28 with a primary completion date of 2032-04-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV/AIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.
Eligibility Criteria
Inclusion Criteria: * CSF cryptococcal antigen (CrAg) positive meningitis * Living with HIV * Ability and willingness to provide informed consent * Willing to receive protocol-specified lumbar punctures * Age \>= 18 years * Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix). Exclusion Criteria: * Received 3 or more doses of antifungal therapy for meningitis within last 30 days * Inability to take enteral (oral or nasogastric) medicine * Cannot or unlikely to attend regular clinic visits * Receiving chemotherapy or corticosteroids * Receiving hemodialysis or known liver cirrhosis * Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS) * Pregnancy or breastfeeding * Previous administration of investigational study drug * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments * Trial Appendix study-drug specific eligibility criteria
Contact & Investigator
David R Boulware, MD, MPH
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06666322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06666322 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06666322 currently recruiting?
Yes, NCT06666322 is actively recruiting participants. Contact the research team at coat.trial@gmail.com for enrollment information.
Where is the NCT06666322 trial being conducted?
This trial is being conducted at Kampala, Uganda, Mbarara, Uganda.
Who is sponsoring the NCT06666322 clinical trial?
NCT06666322 is sponsored by University of Minnesota. The principal investigator is David R Boulware, MD, MPH at University of Minnesota. The trial plans to enroll 2,000 participants.
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