ISRCTN72509687.
Trial name or title | High dose AMBISOME on a fluconazole backbone for cryptococcal meningitis induction therapy in sub‐Saharan Africa |
Methods | Phase 3 non‐inferiority RCT from 6 sites in South Africa, Botswana, Zimbabwe, Malawi, and Uganda with planned enrolment of 850 participants |
Participants | Age ≥ 18 years with first episode of HIV‐associated cryptococcal meningitis |
Interventions | (i) Single dose of 10 mg/kg IV liposomal AmB with 2 weeks 5FC 100 mg/kg/day and FLU 1200 mg/day (ii) 1 week of AmBd 1 mg/kg/day and 5FC 100 mg/kg/day followed by FLU 1200 mg/day days 8 to 14 |
Outcomes | Primary: 10‐week mortality |
Starting date | 2017 |
Contact information | joseph.jarvis@lshtm.ac.uk |
Notes | Original protocol was to compare short‐course L‐AmB and 2 weeks of AmBd with FLU as a second drug for both regimens; however, protocol was modified after results from Molloy 2018 study became available showing mortality benefit with 1 week of AmBd and 5FC followed by FLU days 8 to 14. |