Status:
COMPLETED
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Infectious Disease Institute, Kampala, Uganda
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Cryptococcal Meningitis
Fungal Meningitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 CS...
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 meningi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2017
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT01802385
Start Date
March 9 2015
End Date
September 27 2017
Last Update
June 9 2020
Active Locations (2)
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1
Infectious Disease Institute
Kampala, Uganda
2
Mbarara University of Science and Technology
Mbarara, Uganda