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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Study acronym: ACACIA
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary completion date: Oct 2027 to Jun 2027
    • Study completion date: Apr 2028 to Aug 2027
    v7
  2. Primary completion date: May 2027 to Oct 2027
    • Study completion date: Nov 2027 to Apr 2028
    v6
  3. Eligibility criteria expanded, about 3 wordsv5
  4. Enrollment target: 600 to 356
    • Primary completion date: May 2023 to May 2027
    • Study completion date: Nov 2023 to Nov 2027
    • Eligibility criteria expanded, about 6 words
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2019 to Jun 20, 2019
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda. Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy. How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.
Trial Details
NCT Number NCT03945448
Lead Sponsor Makerere University
Collaborators: University of Minnesota, Gilead Sciences
Conditions
(from sponsor)		 Cryptococcal Meningitis
Related terms Meningitis, Cryptococcal
Enrollment 356 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov