Efficacy of adjunctive sertraline for the treatment of HIV-associated cryptococcal meningitis: An open-label dose-ranging study

The Lancet Infectious Diseases

Volumn 16, Issue 7, 2016, Pages 809-818

  Rhein, Joshua ^a,b   Morawski, Bozena M ^a   Hullsiek, Kathy Huppler ^a   Nabeta, Henry W ^b   Kiggundu, Reuben ^b   Tugume, Lillian ^b   Musubire, Abdu ^b   Akampurira, Andrew ^b   Smith, Kyle D ^a   Alhadab, Ali ^a   Williams, Darlisha A ^a,b   Abassi, Mahsa ^a,b   Bahr, Nathan C ^a,b   Velamakanni, Sruti S ^a   Fisher, James ^a   Nielsen, Kirsten ^a   Meya, David B ^a,b   Boulware, David R ^a   Ndyetukira, Jane Francis ^b   Ahimbisibwe, Cynthia ^b   Kugonza, Florence ^b   Sadiq, Alisat ^b   Kandole, Tadeo Kiiza ^b   Luggya, Tony ^b   Kaboggoza, Julian ^b   Laker, Eva ^b   Butler, Elissa K ^b   Dyal, Jonathan ^b   Neborak, Julie M ^b   King, Alexa M ^b   Fujita, A Wendy ^b   Yueh, Nathan ^b   Namudde, Alice ^b   Halupnick, Ryan ^b   Jawed, Bilal ^b   Vedula, Priya ^b   Peterson, Marnie ^b   Bohjanen, Paul R ^b   Kambugu, Andrew ^b   more..

^a UNIVERSITY OF MINNESOTA   (United States)

^b MAKERERE UNIVERSITY   (Uganda)

Author keywords

[No Author keywords available]

Indexed keywords

AMPHOTERICIN B; EFAVIRENZ; FLUCONAZOLE; NEVIRAPINE; PLACEBO; RIFAMPICIN; SERTRALINE; ANTIDEPRESSANT AGENT;

ADD ON THERAPY; ADULT; ANTIVIRAL THERAPY; ARTICLE; CEREBROSPINAL FLUID; CONTROLLED STUDY; CRYPTOCOCCAL MENINGITIS; DIARRHEA; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FUNGICIDAL ACTIVITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME; MAJOR CLINICAL STUDY; MALE; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SEROTONIN SYNDROME; UGANDA; VOMITING; AIDS-RELATED OPPORTUNISTIC INFECTIONS; CLINICAL TRIAL; FILOBASIDIELLA; HIV INFECTIONS; INCIDENCE; ISOLATION AND PURIFICATION; MENINGITIS, CRYPTOCOCCAL; TREATMENT OUTCOME;

ADULT; AIDS-RELATED OPPORTUNISTIC INFECTIONS; ANTIDEPRESSIVE AGENTS; CRYPTOCOCCUS; FEMALE; HIV INFECTIONS; HUMANS; INCIDENCE; MALE; MENINGITIS, CRYPTOCOCCAL; SERTRALINE; TREATMENT OUTCOME;

EID: 84959866307     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(16)00074-8     Document Type: Article

References (35)

1. Park BJ, Wannemuehler KA, Marston BJ, Govender N, Pappas PG, Chiller TM Estimation of the current global burden of cryptococcal meningitis among persons living with HIV/AIDS. AIDS 2009, 23:525-530.
2. Durski KN, Kuntz KM, Yasukawa K, Virnig BA, Meya DB, Boulware DR Cost-effective diagnostic checklists for meningitis in resource-limited settings. J Acquir Immune Defic Syndr 2013, 63:e101-e108.
3. Day JN, Chau TT, Wolbers M, et al. Combination antifungal therapy for cryptococcal meningitis. N Engl J Med 2013, 368:1291-1302.
4. Jarvis JN, Bicanic T, Loyse A, et al. Determinants of mortality in a combined cohort of 501 patients with HIV-associated cryptococcal meningitis: implications for improving outcomes. Clin Infect Dis 2014, 58:736-745.
5. Boulware DR, Meya DB, Muzoora C, et al. Timing of antiretroviral therapy after diagnosis of cryptococcal meningitis. N Engl J Med 2014, 370:2487-2498.
6. Zhai B, Wu C, Wang L, Sachs MS, Lin X The antidepressant sertraline provides a promising therapeutic option for neurotropic cryptococcal infections. Antimicrob Agents Chemother 2012, 56:3758-3766.
7. Smith KD, Achan B, Hullsiek KH, et al. Increased antifungal drug resistance in clinical isolates of Cryptococcus neoformans in Uganda. Antimicrob Agents Chemother 2015, 59:7197-7204.
8. Treviño-Rangel RJ, Villanueva-Lozano H, Hernandez-Rodriguez P, et al. Activity of sertraline against Cryptococcus neoformans: in vitro and in vivo assays. Med Mycol 2016, 54. published online Dec 24. 10.1093/mmy/myv109.
9. Lewis RJ, Angier MK, Williamson KS, Johnson RD Analysis of sertraline in postmortem fluids and tissues in 11 aviation accident victims. J Anal Toxicol 2013, 37:208-216.
10. Nayak R, Xu J Effects of sertraline hydrochloride and fluconazole combinations on Cryptococcus neoformans and Cryptococcus gattii. Mycology 2010, 1:99-105.
11. Spitzer M, Griffiths E, Blakely KM, et al. Cross-species discovery of syncretic drug combinations that potentiate the antifungal fluconazole. Mol Syst Biol 2011, 7:499.
12. Bicanic T, Meintjes G, Wood R, et al. Fungal burden, early fungicidal activity, and outcome in cryptococcal meningitis in antiretroviral-naive or antiretroviral-experienced patients treated with amphotericin B or fluconazole. Clin Infect Dis 2007, 45:76-80.
13. Dyal J, Akampurira A, Rhein J, et al. Reproducibility of CSF quantitative culture methods for estimating rate of clearance in cryptococcal meningitis. Med Mycol 2016, published online Jan 14, 2016. 10.1093/mmy/myv104.
14. Reference method for broth dilution antifungal susceptibility testing of yeasts; approved standard-3d edn. CLSI document M27-A3 2008, CLSI, Clinical and Laboratory Standards Institute, Wayne, PA.
15. Haddow LJ, Colebunders R, Meintjes G, et al. Cryptococcal immune reconstitution inflammatory syndrome in HIV-1-infected individuals: proposed clinical case definitions. Lancet Infect Dis 2010, 10:791-802.
16. Wiesner DL, Moskalenko O, Corcoran JM, et al. Cryptococcal genotype influences immunologic response and human clinical outcome after meningitis. MBio 2012, 3:e00196-e00212.
17. Bicanic T, Muzoora C, Brouwer AE, et al. Independent association between rate of clearance of infection and clinical outcome of HIV associated cryptococcal meningitis: analysis of a combined cohort of 262 patients. Clin Infect Dis 2009, 49:702-709.
18. Longley N, Muzoora C, Taseera K, et al. Dose response effect of high-dose fluconazole for HIV-associated cryptococcal meningitis in southwestern Uganda. Clin Infect Dis 2008, 47:1556-1561.
19. Loyse A, Thangaraj H, Easterbrook P, et al. Cryptococcal meningitis: improving access to essential antifungal medicines in resource-poor countries. Lancet Infect Dis 2013, 13:629-637.
20. Bicanic T, Harrison T, Niepieklo A, Dyakopu N, Meintjes G Symptomatic relapse of HIV-associated cryptococcal meningitis after initial fluconazole monotherapy: the role of fluconazole resistance and immune reconstitution. Clin Infect Dis 2006, 43:1069-1073.
21. Robinson PA, Bauer M, Leal MA, et al. Early mycological treatment failure in AIDS-associated cryptococcal meningitis. Clin Infect Dis 1999, 28:82-92.
22. van der Horst CM, Saag MS, Cloud GA, et al. Treatment of cryptococcal meningitis associated with the acquired immunodeficiency syndrome. N Engl J Med 1997, 337:15-21.
23. Chang CC, Dorasamy AA, Gosnell BI, et al. Clinical and mycological predictors of cryptococcosis-associated immune reconstitution inflammatory syndrome. AIDS 2013, 27:2089-2099.
24. Carlson RD, Rolfes MA, Birkenkamp KE, et al. Predictors of neurocognitive outcomes on antiretroviral therapy after cryptococcal meningitis: a prospective cohort study. Metab Brain Dis 2014, 29:269-279.
25. Meya DB, Manabe YC, Castelnuovo B, et al. Cost-effectiveness of serum cryptococcal antigen screening to prevent deaths among HIV-infected persons with a CD4+ cell count < or = 100 cells/microL who start HIV therapy in resource-limited settings. Clin Infect Dis 2010, 51:448-455.
26. Rajasingham R, Meya DB, Boulware DR Integrating cryptococcal antigen screening and pre-emptive treatment into routine HIV care. J Acquir Immune Defic Syndr 2012, 59:e85-e91.
27. Boulware DR, Meya DB, Bergemann TL, et al. Clinical features and serum biomarkers in HIV immune reconstitution inflammatory syndrome after cryptococcal meningitis: a prospective cohort study. PLoS Med 2010, 7:e1000384.
28. Maes M, Song C, Lin AH, et al. Negative immunoregulatory effects of antidepressants: inhibition of interferon-gamma and stimulation of interleukin-10 secretion. Neuropsychopharmacology 1999, 20:370-379.
29. National Prescription Audit IMS Health, (accessed July 1, 2015). http://www.imshealth.com/en/thought-leadership/ims-institute/reports/medicines-use-in-the-us-2014.
30. DeVane CL, Liston HL, Markowitz JS Clinical pharmacokinetics of sertraline. Clin Pharmacokinet 2002, 41:1247-1266.
31. Naranjo CA, Sproule BA, Knoke DM Metabolic interactions of central nervous system medications and selective serotonin reuptake inhibitors. Int Clin Psychopharmacol 1999, 14(suppl 2):S35-S47.
32. Ruiz NM, Labriola DF, Fiske WD, Joshi AS, Manion DJ, Villano SA. Efavirenz plasma levels and therapeutic response are affected in patients concomitantly receiving selective serotonin reuptake inhibitors. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy. Toronto, Canada; 2000.
33. Markowitz JS, DeVane CL Rifampin-induced selective serotonin reuptake inhibitor withdrawal syndrome in a patient treated with sertraline. J Clin Psychopharmacol 2000, 20:109-110.
34. Tremaine LM, Welch WM, Ronfeld RA Metabolism and disposition of the 5-hydroxytryptamine uptake blocker sertraline in the rat and dog. Drug Metab Dispos 1989, 17:542-550.
35. Bellmann R Clinical pharmacokinetics of systemically administered antimycotics. Curr Clin Pharmacol 2007, 2:37-58.