A Phase 2/3 interventional study of Single dose liposomal Amphotericin and Fluconazole and Fluconazole in Cryptococcal Meningitis, sponsored by Makerere University. Recruiting at 1 site in Uganda. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Makerere University · Phase 2/3, Interventional, and Prevention
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.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
This study's planned enrollment of 356 is above the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.
Browse Meningitis, Cryptococcal studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: Single dose Ambisome 10mg/kg and Fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months. (standard of care therapy)
Drug: Single dose liposomal Amphotericin and Fluconazole
Standard of care pre-emptive treatment fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months
Drug: Fluconazole
Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.
Also known as: AMBISOME and fluconazole
Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months
Number 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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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