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Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
Sponsor: University of Minnesota
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
664
Start Date
2026-05-01
Completion Date
2030-12-31
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
LAmB B
intravenous liposomal amphotericin B (10mg/kg)
Posaconazole
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
World Health Organization (WHO)-recommended SOC
daily intravenous liposomal amphotericin B 3mg/kg, for 2 weeks or at least 7 days if felt stable for discharge per the clinician
WHO-recommended SOC Itraconazole
200mg capsules three times daily x 3 days then twice daily
Locations (2)
University of Minnesota
Minneapolis, Minnesota, United States
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Brazil