NCT01802385

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cryptococcal Meningitis
• Fungal Meningitis

Interventions

Type	Name	Description
DRUG	Sertraline	Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks.

Timeline

• Start date: 2015-03-09
• Primary completion: 2017-09-01
• Completion: 2017-09-27
• First posted: 2013-03-01
• Last updated: 2020-06-09
• Results posted: 2020-01-13

Locations

2 sites across 1 country: Uganda