NCT07261150

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 664 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Histoplasmosis

Interventions

Type	Name	Description
DRUG	LAmB B	intravenous liposomal amphotericin B (10mg/kg)
DRUG	Posaconazole	Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
DRUG	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
DRUG	WHO-recommended SOC Itraconazole	200mg capsules three times daily x 3 days then twice daily

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2025-12-03
• Last updated: 2026-02-09

Locations

2 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study