MedTrace Logo

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

NCT01802385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2020-06-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Cryptococcal Meningitis
  • Fungal Meningitis

Interventions

DRUG

Sertraline

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

Sponsors & Collaborators

  • Infectious Disease Institute, Kampala, Uganda

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Mbarara University of Science and Technology

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • Wellcome Trust

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • University of Minnesota

    lead OTHER

Principal Investigators

  • David B Meya, MBCHB MMed · Infectious Disease Institute

  • Joshua Rhein, MD · University of Minnesota

  • David R Boulware, MD MPH · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-09
Primary Completion
2017-09-30
Completion
2017-09-27

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802385 on ClinicalTrials.gov