Participants
AIDS, meningtis, CM
HIV-1 INFECTION, AIDS, CRYPTOCOCCAL MENINGITIS
Participants 16 years and older with HIV presenting with the first episode of CM, able to take oral medication and provide signed informed consent were recruited. Nasogastric tube, but not intravenous administration of FCZ was permitted. HIV-1 infection was documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay test kit at any time prior to study entry and confirmed within 10 days after study entry. Pregnant and breastfeeding women were excluded. Women of childbearing potential and participating in sexual activity were to use at least two Division of AIDS (DAIDS) approved contraception methods simultaneously. Participants were recruited across 10 international sites.Cryptococcal meningitis had to be documented by a positive CSF cryptococcal culture, a positive CSF India-ink preparation, or a positive CSF cryptococcal antigen latex agglutination test within 7 days prior to entry. Participants were permitted enrollment with CM that was documented solely by a test result from a referring laboratory. Cryptococcal meningtis had to be confirmed by CSF antigen testing by Day 5 at a DAIDS approved laboratory. Treatment was commenced while awaiting confirmation.Participants on ART prior to entry were excluded from Stage-1. Participants were permitted to commence ART after at least 4 weeks of CM treatment as per local standard of care [Participants with electrocardiogram (ECG) QTc prolongation greater than 450msec and those receiving concomitant medications documented to prolong QT interval were excluded [