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NOT YET RECRUITING
NCT07261150
PHASE3

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

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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

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

Locations (2)

University of Minnesota

Minneapolis, Minnesota, United States

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Brazil