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Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 years 10 months later Aug 28, 2026 → Jul 1, 2032
See other at-risk trials from Federal University of Health Science of Porto Alegre

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 28, 2026 to Jul 1, 2032
    • Study completion pushed from Nov 28, 2026 to Jul 1, 2032
    v8
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 28, 2025 to Aug 28, 2026
    • Study sites: 1 to 5
    • Start date changed from estimate of Nov 1, 2024 to Jan 16, 2025
    v7
  3. Eligibility criteria shortened, about 17 wordsv6
  4. Primary endpoint revised
    • Secondary endpoints revised (7)
    v5
  5. Primary completion date: May 28, 2025 to Nov 28, 2025v4 Show 7 more changesShow less
    • Start date: Mar 1, 2024 to Nov 1, 2024
    • Enrollment target: 254 to 279
    • Study completion date: May 28, 2026 to Nov 28, 2026
    • Eligibility criteria expanded, about 78 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 583 words
    • Collaborators expanded, about 14 words
Show 2 earlier versionsHide 2 earlier versions
  1. Secondary endpoints revised (6)v3
  2. Enrollment target: 120 to 254v2 Show 10 more changesShow less
    • Start date: Sep 1, 2023 to Mar 1, 2024
    • Primary endpoints: 2 to 1
    • Study sites: 0 to 1
    • Primary completion date: Feb 28, 2025 to May 28, 2025
    • Study completion date: Feb 28, 2026 to May 28, 2026
    • Interventions: Liposomal Amphotericin B (Drug) to L-AmB standard dose (Drug), Single high dose of liposomal amphotericin B (Drug)
    • Eligibility criteria expanded, about 83 words
    • Secondary endpoints: 2 to 6
    • Study description expanded, about 141 words
    • Study title expanded, about 2 words
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).
Trial Details
NCT Number NCT05814432
Lead Sponsor Federal University of Health Science of Porto Alegre
Collaborators: Gilead Sciences, Financiadora de Estudos e Projetos, Sociedade Gaucha de Infectologia, Immuno-mycologics, Inc. (IMMY)
Conditions
(from sponsor)		 Disseminated Histoplasma Capsulatum Infection, AIDS and Infections, Immunosuppression, Fungal Infection
Related terms Acquired Immunodeficiency Syndrome, Histoplasmosis, Infections, Mycoses
Enrollment 279 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov