Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Collaborator: University of Minnesota
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• CSF cryptococcal antigen (CrAg) positive meningitis

• Ability and willingness to provide informed consent

• Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

• Glasgow Coma Scale < 15 at time of consent

• Received >= 3 doses of amphotericin B within prior 30 days

• Inability to take enteral (oral or nasogastric) medicine

• Cannot or unlikely to attend regular clinic visits

• Receiving chemotherapy or corticosteroids

• Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS)

• Pregnancy or breastfeeding

• Previous administration of MAT2203

• Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments