Project Title: Adjunctive Sertraline for the Treatment of HIV -Associated Cryptococcal Meningitis
Project Description: Improving Diagnostics and Neurocognitive Outcomes in HIV/AIDS-related Meningitis This is a phase III randomized trial to evaluate the effect of sertraline when added to standard therapy for CM, with the hypothesis that adjunctive sertraline will lead to faster fungal clearance from the brain parenchyma and improved survival. CM diagnosis will be made via CSF cryptococcal antigen (CRAG) at time of lumbar puncture (LP) with confirmation by CSF culture. After informed consent, subjects with CM who... Improving Diagnostics and Neurocognitive Outcomes in HIV/AIDS-related Meningitis This is a phase III randomized trial to evaluate the effect of sertraline when added to standard therapy for CM, with the hypothesis that adjunctive sertraline will lead to faster fungal clearance from the brain parenchyma and improved survival. CM diagnosis will be made via CSF cryptococcal antigen (CRAG) at time of lumbar puncture (LP) with confirmation by CSF culture. After informed consent, subjects with CM who meet eligibility requirements will be enrolled. 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 stratified by clinical site.Total anticipated enrollment: 550 subjects. CSF from the LPs at diagnosis, day 3, day 7, day 10, and day 14 will be sent for PK studies and for quantitative cryptococcal culture. Quantitative cultures will be used to calculate early fungicidal activity (EFA) over 14-days, and we will compare EFA between study arms.
Principal Investigator : Sarah Moore
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