Cryptococcal Meningitis Clinical Trial
Official title:
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
This is a phase III trial to determine whether adjunctive sertraline will lead to improved
survival 18-week survival.
There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF
concentrations in 172 persons conducted from August 2013 to August 2014. See NCT03002012.
This is a phase III randomized trial to evaluate whether sertraline when added to standard
amphotericin-based therapy for cryptococcal meningitis, will lead to improved survival .
Cryptococcal meningitis diagnosis will be made via CSF cryptococcal antigen (CRAG) at time of
lumbar puncture (LP) with confirmation by CSF culture. After informed consent, subjects that
meet eligibility requirements will be able to enter study. A non-randomized phase I
dose-escalation study will first be conducted to help optimize dosing for a larger randomized
phase II study.
Phase III Design: Subjects will be randomized to standard induction therapy with masked
placebo or sertraline at 400mg/day. We will use a permutated block randomization in a 1:1
allocation (n=275 per arm). Total anticipated enrollment: 550 subjects.
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