Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)

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.

NCT Number	NCT07261150
Lead Sponsor	University of Minnesota Collaborators: Federal University of Health Science of Porto Alegre
Conditions	Histoplasmosis
Enrollment	664 participants
Start Date	2026-09-15
Primary Completion	2030-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-08