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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.
Clin Infect Dis. 2006 Jul 01; 43(1):79-89.CI

Abstract

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 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+Show Affiliations

Institut d'Investigacions Biomediques August Pi-Sunyer-Hospital Clinic, University of Barcelona, Barcelona, Spain. jmmiro@ub.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16758422

Citation

Miro, Jose M., et al. "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." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 43, no. 1, 2006, pp. 79-89.
Miro JM, Lopez JC, Podzamczer D, et al. 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. Clin Infect Dis. 2006;43(1):79-89.
Miro, J. M., Lopez, J. C., Podzamczer, D., Peña, J. M., Alberdi, J. C., Martínez, E., Domingo, P., Cosin, J., Claramonte, X., Arribas, J. R., Santín, M., & Ribera, E. (2006). 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. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 43(1), 79-89.
Miro JM, et al. 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. Clin Infect Dis. 2006 Jul 1;43(1):79-89. PubMed PMID: 16758422.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Miro,Jose M, AU - Lopez,Juan C, AU - Podzamczer,Daniel, AU - Peña,Jose M, AU - Alberdi,Juan C, AU - Martínez,Esteban, AU - Domingo,Pere, AU - Cosin,Jaime, AU - Claramonte,Xavier, AU - Arribas,Jose R, AU - Santín,Miguel, AU - Ribera,Esteban, AU - ,, Y1 - 2006/05/31/ PY - 2005/11/06/received PY - 2006/03/13/accepted PY - 2006/6/8/pubmed PY - 2006/8/23/medline PY - 2006/6/8/entrez SP - 79 EP - 89 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 43 IS - 1 N2 - 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 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. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/16758422/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_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/504872 DB - PRIME DP - Unbound Medicine ER -