Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
NCT ID: NCT07261150
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
664 participants
INTERVENTIONAL
2026-02-01
2030-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Induction Therapy - Experimental
Single high-dose (10mgkg) of LAmB B
LAmB B
intravenous liposomal amphotericin B (10mg/kg)
Induction Therapy - Standard of Care
SOC daily standard dose (3mg/kg) LAmB
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
Consolidation Therapy - Experimental
posaconazole
Posaconazole
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
Consolidation Therapy - Standard of Care
SOC itraconazole
WHO-recommended SOC Itraconazole
200mg capsules three times daily x 3 days then twice daily
Total Consolidation - Experimental
6 months total (e.g., 0 additional months) of itraconazole or posaconazole based on assignment from Aim 2.
Posaconazole
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
WHO-recommended SOC Itraconazole
200mg capsules three times daily x 3 days then twice daily
Total Consolidation - Standard of Care
12 months total (e.g., 6 additional months) of itraconazole or posaconazole based on assignment from Aim 2
Posaconazole
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
WHO-recommended SOC Itraconazole
200mg capsules three times daily x 3 days then twice daily
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Hospitalized with suspected histoplasmosis b
* Diagnosis of confirmed or probable histoplasmosis (via positive Histoplasma antigen test, culture, histopathology or microscopy)
* Provision of Informed Consent by participant or surrogate c
Exclusion Criteria
* Pregnant persons (all persons who could potentially be pregnant will have a pregnancy test prior to enrollment, and if negative, must agree to contraception for the duration of the study)
* Breastfeeding and unable to stop for the duration of the study
* Renal impairment (serum creatinine or blood urea nitrogen (BUN) \>2.0x upper limit of normal)
* Allergy or contraindication to a study medicine
* More than one dose of an amphotericin product in the prior 7 days
* Suspected central nervous system involvement of histoplasmosis
* Likely to die in the next 48 hours in the judgment of the investigator
* Unlikely to follow up for the duration of the study in the judgement of the investigator
* Significant drug-drug interaction with itraconazole or posaconazole (such as rifampin in persons with TB)
* Current diagnosis of cryptococcosis or leishmaniasis
* QTc interval consistently \>450 milliseconds
* Prisoners
* Unable to take oral medications
18 Years
ALL
No
Sponsors
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Federal University of Health Science of Porto Alegre
OTHER
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Nathan Bahr, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IDIM-2025-33491
Identifier Type: -
Identifier Source: org_study_id