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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05814432 | Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS | PHASE3 | RECRUITING | 279 | — | — | Jan 16, 2025 | Nov 28, 2026 | Feb 4, 2025 | 5 | Brazil |
Overall mortality (from any cause) will be determined on day 14 of the study
| Arm | Type | Description |
|---|---|---|
| Single high dose arm | EXPERIMENTAL | Single high dose of liposomal amphotericin B (10 mg/kg) |
| Standard dose arm | ACTIVE_COMPARATOR | Standard treatment with 3 mg/kg of liposomal amphotericin B daily for 2 weeks |
| Name | Type | Description |
|---|---|---|
| Single high dose of liposomal amphotericin B | DRUG | Single high dose (10 mg/kg) of liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS |
| L-AmB standard dose | DRUG | Standard treatment (3 mg/kg for two weeks) with liposomal amphotericin B as induction therapy for disseminated histoplasmosis in AIDS |
Inclusion Criteria: * Adult patients admitted to the centers that will be part of the study * Infected by the HIV, regardless of the use of antiretroviral therapy * Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology...