Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial

MB-70007

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.

2019-10-24

2022-11-14

2023-02-15

Completed

Early phase I

178

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase I: Persons in Uganda without meningitis or active infections Phase II: HIV-infected persons in Uganda with cryptococcal meningitis', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 178, 'type': 'ACTUAL'}}

2023-03-31