Document 0244 DOCN M9440244 TI Primary prophylaxis with pyrimethamine for toxoplasmic encephalitis in patients with advanced human immunodeficiency virus disease: results of a randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS. DT 9404 AU Jacobson MA; Besch CL; Child C; Hafner R; Matts JP; Muth K; Wentworth DN; Neaton JD; Abrams D; Rimland D; et al; Department of Medicine, University of California, San Francisco. SO J Infect Dis. 1994 Feb;169(2):384-94. Unique Identifier : AIDSLINE MED/94149325 AB Pyrimethamine, 25 mg thrice weekly, was evaluated as primary prophylaxis for toxoplasmic encephalitis (TE) in a double-blind, randomized clinical trial in patients with human immunodeficiency virus (HIV) disease, absolute CD4 lymphocyte count of < 200/microL (or prior AIDS-defining opportunistic infection), and the presence of serum IgG to Toxoplasma gondii. Leucovorin was coadministered only for hematologic toxicity. There was a significantly higher death rate among patients receiving pyrimethamine (relative risk [RR], 2.5; 95% confidence interval [CI], 1.3-4.8; P = .006), even after adjusting for factors predictive of survival. The TE event rate was low in both treatment groups (not significant). Only 1 of 218 patients taking trimethoprim-sulfamethoxazole but 7 of 117 taking aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia developed TE (adjusted RR for the trimethoprim-sulfamethoxazole group, 0.16; 95% CI, 0.01-1.79; P = .14). Thus, for HIV-infected patients receiving trimethoprim-sulfamethoxazole, additional prophylaxis for TE appears unnecessary. DE Adult AIDS-Related Opportunistic Infections/*DRUG THERAPY/MORTALITY Female Human HIV Infections/*COMPLICATIONS Male Middle Age Pneumonia, Pneumocystis carinii/COMPLICATIONS/MORTALITY Pyrimethamine/*ADVERSE EFFECTS Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S. Toxoplasmosis, Cerebral/*PREVENTION & CONTROL CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL SOURCE: National Library of Medicine. NOTICE: This material may be protected by Copyright Law (Title 17, U.S.Code).