BACKGROUND: To our knowledge, no randomized trials have evaluated whether prophylaxis against toxoplasmic encephalitis can be safely discontinued after the CD4+ T cell count increases in response to highly active antiretroviral therapy. METHODS: We conducted a randomized, nonblinded, multicenter clinical trial of the discontinuation of primary or secondary prophylaxis against toxoplasmic encephalitis in human immunodeficiency virus (HIV)-infected patients with a sustained response to antiretroviral therapy (defined as a CD4+ T cell count of > or =200 cells/mm3 and a plasma HIV type 1 [HIV-1] RNA level of <5000 copies/mL for at least 3 months). Prophylaxis was restarted if the CD4+ T cell count decreased to <200 cells/mm3. RESULTS: The 381 patients receivingprimary prophylaxis had a median CD4+ T cell count on study entry of 343 cells/mm3, and 318 (83%) of 381 patients had undetectable HIV-1 RNA in plasma. After a median follow-up period of 25 months (409 person-years), there were no episodes of toxoplasmic encephalitis among the 196 patients who discontinued prophylaxis (at 1 year, the upper limit of the 95% confidence interval for relapse rate was 2.40%). For the 57 patients receiving secondary prophylaxis, the median CD4+ T cell count on entry was 407 cells/mm3, and 49 (86%) of 57 patients had undetectable HIV-1 RNA in plasma. After a median follow-up period of 30.5 months (69 person-years), there were no episodes of toxoplasmic encephalitis among the 28 patients who discontinued prophylaxis (at 1 year, the upper limit of the 95% confidence interval for relapse rate was 16%). CONCLUSIONS: In HIV-infected adult patients receiving effective highly active antiretroviral therapy, primary and secondary prophylaxis against toxoplasmic encephalitis can be safely discontinued after the CD4+ T cell count has increased to > or =200 cells/mm3 for >3 months.
RCT Entities:
BACKGROUND: To our knowledge, no randomized trials have evaluated whether prophylaxis against toxoplasmic encephalitis can be safely discontinued after the CD4+ T cell count increases in response to highly active antiretroviral therapy. METHODS: We conducted a randomized, nonblinded, multicenter clinical trial of the discontinuation of primary or secondary prophylaxis against toxoplasmic encephalitis in human immunodeficiency virus (HIV)-infectedpatients with a sustained response to antiretroviral therapy (defined as a CD4+ T cell count of > or =200 cells/mm3 and a plasma HIV type 1 [HIV-1] RNA level of <5000 copies/mL for at least 3 months). Prophylaxis was restarted if the CD4+ T cell count decreased to <200 cells/mm3. RESULTS: The 381 patients receiving primary prophylaxis had a median CD4+ T cell count on study entry of 343 cells/mm3, and 318 (83%) of 381 patients had undetectable HIV-1 RNA in plasma. After a median follow-up period of 25 months (409 person-years), there were no episodes of toxoplasmic encephalitis among the 196 patients who discontinued prophylaxis (at 1 year, the upper limit of the 95% confidence interval for relapse rate was 2.40%). For the 57 patients receiving secondary prophylaxis, the median CD4+ T cell count on entry was 407 cells/mm3, and 49 (86%) of 57 patients had undetectable HIV-1 RNA in plasma. After a median follow-up period of 30.5 months (69 person-years), there were no episodes of toxoplasmic encephalitis among the 28 patients who discontinued prophylaxis (at 1 year, the upper limit of the 95% confidence interval for relapse rate was 16%). CONCLUSIONS: In HIV-infected adult patients receiving effective highly active antiretroviral therapy, primary and secondary prophylaxis against toxoplasmic encephalitis can be safely discontinued after the CD4+ T cell count has increased to > or =200 cells/mm3 for >3 months.
Authors: George K Siberry; Mark J Abzug; Sharon Nachman; Michael T Brady; Kenneth L Dominguez; Edward Handelsman; Lynne M Mofenson; Steve Nesheim Journal: Pediatr Infect Dis J Date: 2013-11 Impact factor: 2.129
Authors: Lyle R McKinnon; Makobu Kimani; Charles Wachihi; Nico J Nagelkerke; Festus K Muriuki; Anthony Kariri; Richard T Lester; Lawrence Gelmon; T Blake Ball; Francis A Plummer; Rupert Kaul; Joshua Kimani Journal: PLoS One Date: 2010-07-02 Impact factor: 3.240
Authors: Lynne M Mofenson; Michael T Brady; Susie P Danner; Kenneth L Dominguez; Rohan Hazra; Edward Handelsman; Peter Havens; Steve Nesheim; Jennifer S Read; Leslie Serchuck; Russell Van Dyke Journal: MMWR Recomm Rep Date: 2009-09-04
Authors: A Antinori; A Ammassari; C Torti; P Marconi; M Andreoni; G Angarano; S Bonora; A Castagna; R Cauda; M Clerici; A d'Arminio Monforte; A De Luca; G Di Perri; M Galli; E Girardi; A Gori; A Lazzarin; S Lo Caputo; F Mazzotta; F Montella; C Mussini; C F Perno; M Puoti; G Rizzardini; S Rusconi; V Vullo; G Carosi Journal: Infection Date: 2009-05-28 Impact factor: 3.553