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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
356
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
infectious Disease Institute Kampala,Uganda
Kampala, Uganda
RECRUITINGNumber of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm.
Comparison will be made between those randomized to single dose liposomal amphotericin + standard of care (fluconazole) vs. standard of care (fluconazole) alone
Time frame: 24 weeks
Number of grade 3 to 5 clinical adverse events or serious adverse events
Symptoms causing inability to perform social and functional activities and potentially life threatening symptoms requiring intervention or hospitalization.
Time frame: within two weeks of enrollment
Number of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scale
Abnormal laboratory findings that meet the DAIDS categorization of grade 3 and 4.
Time frame: within two weeks of enrollment
Cost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy.
what will be the added cost required to treat patients with AMBISOME when assessed in light of the outcomes.
Time frame: 24 weeks
Number of patients that will survive in the 24-week period.
How many patients will be alive at 24 weeks when the two arms are compared.
Time frame: 24 weeks
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