Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

• Status: Completed
• Trial end date: 2017-09-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Ifakara Health Institute; Infectious Disease Institute, Kampala, Uganda; Makerere University; Mbarara University of Science and Technology; Medical Research Council; National Institute of Neurological Disorders and Stroke (NINDS); Wellcome Trust
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)

• HIV-1 infection

• Ability and willingness of the participant or legal guardian/representative to provide informed consent

• Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

• Age < 18 years

• Receipt of >=3 doses of amphotericin therapy

• Cannot or unlikely to attend regular clinic visits

• History of known liver cirrhosis

• Presence of jaundice

• Pregnancy

• Current breastfeeding