Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as two sequential trials. The first is a phase I open label trial to evaluate the safety and tolerability of MAT2203. The maximal tolerated and non-toxic daily dose,will then be moved forward into a multi-day safety trial. The Phase II trial will investigate toxicity and early fungicidal activity (EFA) of MAT2203 with flucytosine.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Collaborators: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• Phase 1:

• Age >18 years

• Calculated creatinine clearance >70 mL/min/1.73 m2 (measured within 3 months)

• Written informed consent

Phase 2:

• Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)

• Ability and willingness to provide informed consent

• Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

• Phase 1:

• Symptomatic Current illness

• Known significant, untreated health problem

• Inability to take enteral medicine

• Pregnant or breast feeding

• Receiving amphotericin B therapy in past 90 days

• Phase 2:

• Presenting Glasgow Coma Scale (GCS) < 15

• Received 3 or more doses of IV amphotericin therapy within last 30 days

• Inability to take enteral (oral or nasogastric) medicine

• Cannot or unlikely to attend regular clinic visits

• Pregnancy or breastfeeding

• Receiving chemotherapy or corticosteroids

• Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)

• Recent initiation of HIV therapy or ART class switch (within 2 weeks)