Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
United States, Brazil664 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality at 2 weeks
Timeframe: Week 2
2
Mortality at 26 weeks
Timeframe: Week 26
3
SAE-free survival between 26 and 52 weeks from induction therapy among those who survived 26 weeks