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?
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.
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.
Start Date: March 9, 2015
Completed Date: September 27, 2017
Phase: Phase 3
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
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.