Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04031833 | Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) | PHASE1 | COMPLETED | 178 | — | — | Oct 24, 2019 | Feb 15, 2023 | Mar 31, 2023 | 1 | Uganda |
Proportion of cAMB daily dose received and tolerated without vomiting within 30 minutes.
CSF early fungicidal activity (EFA) during 2-week induction therapy
| Arm | Type | Description |
|---|---|---|
| Phase 1a single ascending dose study | EXPERIMENTAL | Phase IA will consist of a single ascending dose study in 9 participants to test three doses to determine the max tolerated dose. |
| Phase 1b multiple day dosing | EXPERIMENTAL | 9 subjects will receive the Phase Ia 100% tolerated MAT2203 dose for 7 days. |
| Phase 2 safety and tolerability | EXPERIMENTAL | Safety, tolerability, and microbiologic efficacy of MAT2203 among HIV-infected patients with cryptococcal meningitis compared with standard IV AMB. |
| Name | Type | Description |
|---|---|---|
| MAT2203 | DRUG | Encochleated amphotericin B |
| Amphotericin B | DRUG | Intravenous amphotericin B |
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 ...