Status:
COMPLETED
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)
Lead Sponsor:
Matinas BioPharma Nanotechnologies, Inc.
Collaborating Sponsors:
University of Minnesota
Conditions:
Cryptococcal Meningitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Cryptococcal meningitis has emerged as one of the most frequent and deadly opportunistic infections in HIV patients. Historically, amphotericin B (AMB) has been considered the "gold standard" in antif...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04031833
Start Date
October 24 2019
End Date
February 15 2023
Last Update
March 31 2023
Active Locations (1)
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1
Infectious Disease Institute
Kampala, Uganda