Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04031833
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2019-07-22
Brief Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial EnACT
Sponsor:
Matinas BioPharma Nanotechnologies Inc
Organization:
Matinas BioPharma Nanotechnologies Inc
Study Overview
Official Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EnACT
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 dosewill 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
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None