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Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) — EnACT  

Cryptococcal Meningitis Clinical Trial

Official title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial

Clinical Trial 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.

Clinical Trial 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 antifungal treatments due to its broad spectrum of activity and lack of emergence of resistance. However, the use of AMB is limited by side effects, including nephrotoxicity, anemia, and infusion-related reactions. MAT2203 or encochleated oral amphotericin B (cAMB) is a lipid nano-crystal formulation designed for targeted oral delivery of the antifungal drug AMB for treatment of fungal and parasitic infections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04031833
Study type Interventional
Source Matinas BioPharma Nanotechnologies, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 24, 2019
Completion date February 15, 2023
View Details
See also
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