Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Evaluation of CrAg Screening With Enhanced Antifungal Therapy for Asymptomatic CrAg+ Persons
Makerere University
356 participants
Jun 20, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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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Interventions
Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.
Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03945448