HistoplasmosisPhase 3NCT07261150
Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
A Phase 3 study testing LAmB B, Posaconazole and World Health Organization (WHO)-recommended SOC in people with Histoplasmosis, run by University of Minnesota at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histoplasmosis
- What is being tested?
- LAmB B, Posaconazole and World Health Organization (WHO)-recommended SOC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Nathan Bahr, bahrx026@umn.edu
Brazil1 site
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre
Alessandro Pasqualotto, pasqualotto@santacasa.org.br
About this study
The purpose of the study is threefold:
- 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.
- 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
- 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
- Being tested
- LAmB B, Posaconazole, World Health Organization (WHO)-recommended SOC, WHO-recommended SOC Itraconazole
- Medical subject headings
- Histoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAmB BDrug
intravenous liposomal amphotericin B (10mg/kg)
PosaconazoleDrug
Posaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily
World Health Organization (WHO)-recommended SOCDrug
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 ItraconazoleDrug
200mg capsules three times daily x 3 days then twice daily
| Study group | Role | What they receive |
|---|---|---|
| Induction Therapy - Experimental | Experimental | Single high-dose (10mgkg) of LAmB B Receives: Drug: LAmB B |
| Induction Therapy - Standard of Care | Active comparator | SOC daily standard dose (3mg/kg) LAmB Receives: Drug: World Health Organization (WHO)-recommended SOC |
| Consolidation Therapy - Experimental | Experimental | posaconazole Receives: Drug: Posaconazole |
| Consolidation Therapy - Standard of Care | Active comparator | SOC itraconazole Receives: Drug: WHO-recommended SOC Itraconazole |
| Total Consolidation - Experimental | Experimental | 6 months total (e.g., 0 additional months) of itraconazole or posaconazole based on assignment from Aim 2. Receives: Drug: Posaconazole; Drug: WHO-recommended SOC Itraconazole |
| Total Consolidation - Standard of Care | Active comparator | 12 months total (e.g., 6 additional months) of itraconazole or posaconazole based on assignment from Aim 2 Receives: Drug: Posaconazole; Drug: WHO-recommended SOC Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 2 weeks
Measured: Week 2
Mortality at 26 weeks
Measured: Week 26
SAE-free survival between 26 and 52 weeks from induction therapy among those who survived 26 weeks
Measured: Week 52
Secondary outcomes (2)
Aim 1: Hierarchical composite end point
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
Measured: Week 56
Aim 2: Hierarchical composite end point
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
Measured: Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistoplasmosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 664 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Nathan Bahr, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261150
- Sponsor's protocol ID
- IDIM-2025-33491
- Status last verified
- Nov 2026
- First submitted
- 21 Nov 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)
- ClinicalTrials.gov ID
- NCT07261150
- Acronym / sponsor ID
- IDIM-2025-33491
- Conditions
- Histoplasmosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 664 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is threefold:
- 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.
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Induction Therapy - Experimental | Experimental | Drug: LAmB BSingle high-dose (10mgkg) of LAmB B |
| Induction Therapy - Standard of Care | Active comparator | Drug: World Health Organization (WHO)-recommended SOCSOC daily standard dose (3mg/kg) LAmB |
| Consolidation Therapy - Experimental | Experimental | Drug: Posaconazoleposaconazole |
| Consolidation Therapy - Standard of Care | Active comparator | Drug: WHO-recommended SOC ItraconazoleSOC itraconazole |
| Total Consolidation - Experimental | Experimental | Drug: Posaconazole, Drug: WHO-recommended SOC Itraconazole6 months total (e.g., 0 additional months) of itraconazole or posaconazole based on assignment from Aim 2. |
| Total Consolidation - Standard of Care | Active comparator | Drug: Posaconazole, Drug: WHO-recommended SOC Itraconazole12 months total (e.g., 6 additional months) of itraconazole or posaconazole based on assignment from Aim 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAmB Bintravenous liposomal amphotericin B (10mg/kg) | Drug | Induction Therapy - Experimental |
| PosaconazolePosaconazole delayed-release tabs, 300mg twice daily on day 1 then once daily | Drug | Consolidation Therapy - Experimental, Total Consolidation - Experimental, Total Consolidation - Standard of Care |
| World Health Organization (WHO)-recommended SOCdaily intravenous liposomal amphotericin B 3mg/kg, for 2 weeks or at least 7 days if felt stable for discharge per the clinician | Drug | Induction Therapy - Standard of Care |
| WHO-recommended SOC Itraconazole200mg capsules three times daily x 3 days then twice daily | Drug | Consolidation Therapy - Standard of Care, Total Consolidation - Experimental, Total Consolidation - Standard of Care |
Primary outcome
Mortality at 2 weeks
Time frame: Week 2
Mortality at 26 weeks
Time frame: Week 26
SAE-free survival between 26 and 52 weeks from induction therapy among those who survived 26 weeks
Time frame: Week 52
2 secondary outcomes
Aim 1: Hierarchical composite end point
Time frame: Week 56
Aim 2: Hierarchical composite end point
Time frame: Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Histoplasmosis
Not yet recruitingObservational study
Assessment of the Risk of Zoonotic Infections in Prisons in French Guiana
Q Fever, Leptospirosis
Not yet recruitingPhase 2
Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
Coccidioidomycosis, Blastomycosis
RecruitingPhase 3
Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS
Disseminated Histoplasma Capsulatum Infection, AIDS and Infections
RecruitingPhase 4
A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome
Presumed Ocular Histoplasmosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Bahr, MD principal investigator
University of Minnesota
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LAmB B, Posaconazole and World Health Organization (WHO)-recommended SOC in people with Histoplasmosis, run by University of Minnesota at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Bahr, MD (612-624-9996, bahrx026@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 2 weeks (time frame: Week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.