drugset / Trial / NCT07261150
Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
Phase 3
Not yet recruiting
664 enrolled
University of Minnesota
Federal University of Health Science of Porto Alegre · collab
RandomizedSequentialOpen-labelTreatment
Summary
The purpose of the study is threefold: 1. Assess the safety and efficacy of a single high-dose intravenous (LAmB 10mg/kg) compared to the SOC daily dosing (3mg/kg) of the same medication for induction therapy in moderate to severe histoplasmosis. 2. Assess the safety and efficacy of oral posaconazole 300mg delayed-release tablets three times daily for two days then once daily for consolidation therapy compared to SOC oral itraconazole 200 mg capsules three times daily for three days then twice daily in moderate to severe histoplasmosis 3. Assess the safety and efficacy of 6 months of consolidation therapy compared to the SOC 12 months of consolidation therapy in persons with HIV on appropriate antiretroviral therapy.
Timeline
- Start
- 2026-09-15
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphotericin B | Unknown | 3 mg/kg | Intravenous |
| Subject | Amphotericin B | Unknown | 10 mg/kg | Intravenous |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Posaconazole | Small molecule | 300 mg | Oral |