CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 460 enrolled
Drug / intervention
Sertralinedrug
Likely dose
Sertraline 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01802385
NCT01802385Phase 3Completed
CompareCT.gov

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

University of Minnesota·interventional·Posted Mar 1, 2013·Updated Jun 9, 2020

In Brief

A Phase 3 clinical trial evaluating Sertraline for Cryptococcal Meningitis and Fungal Meningitis. Completed, enrolled 460 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCryptococcal Meningitis, Fungal Meningitis
CountriesUganda
CollaboratorsInfectious Disease Institute, Kampala, Uganda, National Institute of Neurological Disorders and Stroke (NINDS), Mbarara University of Science and Technology, Medical Research Council, Wellcome Trust, Makerere University

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2013
Enrollment StartMar 9, 2015
Primary CompletionSep 1, 2017
Study CompletionSep 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.3 years ago

Interventions

Sertralinedrug

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