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Higher Dose Oral Fluconazole for the Treatment of AIDS-related Cryptococcal Meningitis (HIFLAC)-report of A5225, a multicentre, phase I/II, two-stage, dose-finding, safety, tolerability and efficacy randomised, amphotericin B-controlled trial of the AIDS Clinical Trials Group.

Umesh G LallooLauren KomarowJudith A AbergDavid B CliffordEvelyn HoggAshley McKhannAggrey BukuruDavid LagatSandy PillayVidya MaveKhuanchai SupparatpinyoWadzanai SamanekaDeborah LangatEduardo TiconaSharlaa Badal-FaesenRobert A Larsennull null
Published in: PloS one (2023)
Induction phase weight and renal-adjusted doses of 1600mg and 2000mg/day FCZ for CM were safe and well tolerated except for increased GI side effects in the 2000mg/day dose, and had similar times to achieve CSF sterilization, but took significantly longer than AMB. The WHO recommended 1200mg FCZ was associated with a high mortality. While not statistically significant, mortality was numerically lower in the AMB compared to 1600mg and 2000mg FCZ These data make a case for a phase 3 study of higher doses of FZC.
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