drugset / Trial / NCT03945448
Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
Phase 2/3
Recruiting
356 enrolled
Makerere University
Gilead Sciences · collabUniversity of Minnesota · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2019-06-20
- Primary completion
- 2027-06
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amphotericin B | Unknown | 10 mg/kg | Intravenous |
| Comparator | Fluconazole | Small molecule | 200 mg | — |