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

StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Start date pushed from Oct 1, 2026 to Nov 1, 2026
  2. Start date: Sep 15, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 2 entries
  3. Start date: May 1, 2026 to Sep 15, 2026v4
  4. Start date: Feb 1, 2026 to May 1, 2026v3
  5. Study sites: 0 to 2
    • Collaborators expanded, about 8 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07261150
Lead Sponsor University of Minnesota
Collaborators: Federal University of Health Science of Porto Alegre
Conditions
(from sponsor)		 Histoplasmosis
Related terms Histoplasmosis
Enrollment 664 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov