CompletedPhase 3

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

Uganda460 participantsStarted 2015-03-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Survival

Timeframe: 18 weeks

Trial details

NCT IDNCT01802385

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09

Results submitted2019-05-31

View on ClinicalTrials.gov More Cryptococcal Meningitis trials