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

NCT07261150 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Histoplasmosis

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

Sponsors & Collaborators

Principal Investigators

  • Nathan Bahr, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261150 on ClinicalTrials.gov