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Cryptococcal Meningitis | Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

Cryptococcal Meningitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cryptococcal Meningitis

Fungal Meningitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SertralineSertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboStandard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day).

Sertraline 400mgStandard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.

Study Status

Active, not recruiting

Start Date: March 9, 2015

Completed Date: September 27, 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Survival

Secondary Outcome: Safety

Study sponsors, principal investigator, and references

Principal Investigator: David B Meya, MBCHB MMed

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator: Infectious Disease Institute, Kampala, Uganda

More information:https://clinicaltrials.gov/show/NCT01802385

Rhein J, Morawski BM, Hullsiek KH, Nabeta HW, Kiggundu R, Tugume L, Musubire A, Akampurira A, Smith KD, Alhadab A, Williams DA, Abassi M, Bahr NC, Velamakanni SS, Fisher J, Nielsen K, Meya DB, Boulware DR; ASTRO-CM Study Team. Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: an open-label dose-ranging study. Lancet Infect Dis. 2016 Jul;16(7):809-818. doi: 10.1016/S1473-3099(16)00074-8. Epub 2016 Mar 10.

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