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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

RecruitingPhase 2, Phase 3Ages 15 Years - anyAllMakerere University
NCT03945448 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * HIV-1 infection * Age \> or equal to15 years * Ability and willingness to give informed consent. * Plasma/Serum cryptococcal antigen (CRAG)+ with a titer 1:160 or greater Exclusion Criteria: * Cannot or unlikely to attend regular clinic visits * History of cryptococcal infection * Symptomatic meningitis (confirmed by CSF CRAG+) * \>14 days of fluconazole therapy * Pregnancy (confirmed by urinary or serum pregnancy test) * Current breastfeeding * Known allergy to amphotericin
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What it tests

  • Single dose liposomal Amphotericin and Fluconazole
  • Fluconazole
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Where

1 site
infectious Disease Institute Kampala,Uganda
Kampala, Uganda
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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