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. 2018 Jul 25;2018(7):CD005647. doi: 10.1002/14651858.CD005647.pub3

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.