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Clinical Trial Summary

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).


Clinical Trial Description

Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05541107
Study type Interventional
Source Matinas BioPharma Nanotechnologies, Inc.
Contact Theresa Matkovits, PhD
Phone 908-505-0975
Email tmatkovits@matinasbiopharma.com
Status Not yet recruiting
Phase Phase 3
Start date January 2023
Completion date January 2025

See also
  Status Clinical Trial Phase
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Completed NCT00976040 - Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis Phase 4
Completed NCT04031833 - Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) Phase 1/Phase 2
Completed NCT00830856 - Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa N/A
Completed NCT04532463 - Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis
Completed NCT02098525 - Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy N/A
Completed NCT01075152 - Cryptococcal Optimal ART Timing Trial Phase 4
Active, not recruiting NCT01715922 - Study Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Sub-saharan Africa Phase 2/Phase 3
Completed NCT00145249 - Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis Phase 2
Completed NCT01802385 - Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis Phase 3
Terminated NCT00324025 - Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS Phase 2
Completed NCT02955862 - Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report Phase 1
Recruiting NCT03945448 - Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia Phase 2/Phase 3
Active, not recruiting NCT02624453 - Pre-Antiretroviral Therapy (ART) Cryptococcal Antigen Screening in AIDS N/A
Recruiting NCT00867269 - Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Completed NCT01535469 - Operational Research for Cryptococcal Antigen Screening Phase 4
Active, not recruiting NCT04072640 - Three Induction Treatments on Cryptococcal Meningitis Early Phase 1
Not yet recruiting NCT02686853 - Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Phase 4
Not yet recruiting NCT04140461 - AmB Dose for Cryptococcal Meningitis Phase 3
Completed NCT04296292 - The Lived Experience of Participants in an African Randomised Trial