Journal Article

Discontinuation of Primary and Secondary <i>Toxoplasma gondii</i> Prophylaxis Is Safe in HIV-Infected Patients after Immunological Restoration with Highly Active Antiretroviral Therapy: Results of an Open, Randomized, Multicenter Clinical Trial

Jose M. Miro, Juan C. Lopez, Daniel Podzamczer, Jose M. Peña, Juan C. Alberdi, Esteban Martínez, Pere Domingo, Jaime Cosin, Xavier Claramonte, Jose R. Arribas, Miguel Santín and Esteban Ribera

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 43, issue 1, pages 79-89
Published in print July 2006 | ISSN: 1058-4838
Published online July 2006 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/504872
Discontinuation of Primary and Secondary Toxoplasma gondii Prophylaxis Is Safe in HIV-Infected Patients after Immunological Restoration with Highly Active Antiretroviral Therapy: Results of an Open, Randomized, Multicenter Clinical Trial

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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 ⩾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 ⩾200 cells/mm3 for >3 months.

Journal Article.  5561 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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