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

Conditions

• Histoplasmosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Sep 15, 2026

Status verified

May 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

664 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Induction Therapy - Experimental
  Single high-dose (10mgkg) of LAmB B
• Active Comparator: Induction Therapy - Standard of Care
  SOC daily standard dose (3mg/kg) LAmB
• Experimental: Consolidation Therapy - Experimental
  posaconazole
• Active Comparator: Consolidation Therapy - Standard of Care
  SOC itraconazole
• Experimental: Total Consolidation - Experimental
  6 months total (e.g., 0 additional months) of itraconazole or posaconazole based on assignment from Aim 2.
• Active Comparator: Total Consolidation - Standard of Care
  12 months total (e.g., 6 additional months) of itraconazole or posaconazole based on assignment from Aim 2

Primary Outcome Measure

Mortality at 2 weeks [ Time Frame: Week 2 ]

Central Contacts

• Nathan Bahr, MD
  612-624-9996
  [email protected]

Locations (1)

Find similar trials in Minneapolis, MN