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NCT Number: NCT07261150

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.

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Key information

Conditions

Histoplasmosis Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • 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

  • Previous diagnosis of histoplasmosis
  • 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

Treatment and study plan

LAmB B

Drug

intravenous liposomal amphotericin B (10mg/kg)

Posaconazole

Drug

Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily

World Health Organization (WHO)-recommended SOC

Drug

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

Drug

200mg capsules three times daily x 3 days then twice daily

Primary outcomes

  1. Mortality at 2 weeks

    Time frame: Week 2

  2. Mortality at 26 weeks

    Time frame: Week 26

  3. SAE-free survival between 26 and 52 weeks from induction therapy among those who survived 26 weeks

    Time frame: Week 52

Secondary outcomes

  1. Aim 1: Hierarchical composite end point

    Time frame: Week 56

    Consisting of the following in a hierarchical order:

    5: Death within 10 weeks or lost to follow up in the first 1 week 4: Serious Adverse event within 10 weeks 3: Grade 4 laboratory abnormality at week two visit or discontinuation of medication due to intolerance during the first 10 weeks 2: Grade 3 laboratory abnormality at week two visit

    1: Alive at the end of the study period without one of the above events

  2. Aim 2: Hierarchical composite end point

    Time frame: Week 56

    Consisting of the following in a hierarchical order:

    5: Death within the study period 4: Serious Adverse event within 26 weeks 3: Grade 4 laboratory abnormality through week 26 or discontinuation of medication due to intolerance during the first 26 weeks 2: Grade 3 laboratory abnormality through week 26 or or lost to follow up after the first week

    1: Alive at the end of the study period without one of the above events

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan Bahr, MD

CONTACT

[email protected]

612-624-9996

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Federal University of Health Science of Porto Alegre

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 3, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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