Discontinuation of primary prophylaxis for Pneumocystis carinii pneumonia and toxoplasmic encephalitis in human immunodeficiency virus type I-infected patients: The changes in opportunistic prophylaxis study

A multicenter open, randomized, controlled trial was conducted to determine whether primary proyhylaxis for Pneumocystis carinii pneumonia and toxopla smic encephalitis can be discontinued in patients infected with human immun odeficiency virus type 1 (HIV-1) whose CD4(+) T cell counts have increased to >200 cells/mm(3) (and who have remained at this level for at least 3 mon ths) as a result of highly active antiretroviral therapy (HAART), Patients were randomized to either the discontinuation arm (i.e., those who disconti nued prophylaxis; 355) or to the continuation arm (n = 353); the 2 arms of the study were similar in terms of demographic, clinical, and immunovirolog ic characteristics. During the median follow-ups of 6.4 months (discontinua tion arm) and 6.1 months (continuation arm) and with a total of 419 patient -years, no patient developed P. carinii pneumonia or toxoplasmic encephalit is. The results of this study strongly indicate that primary prophylaxis fo r P. carinii pneumonia and toxoplasmic encephalitis can be safely discontin ued in patients whose CD4(+) T cell counts increase to >200 cells/mm(3) dur ing HAART.