       Document 0219
 DOCN  M9640219
 TI    Pyrimethamine for primary prophylaxis of toxoplasmic encephalitis in
       patients with human immunodeficiency virus infection: a double-blind,
       randomized trial. ANRS 005-ACTG 154 Group Members. Agence Nationale de
       Recherche sur le SIDA. AIDS Clinical Trial Group.
 DT    9604
 AU    Leport C; Chene G; Morlat P; Luft BJ; Rousseau F; Pueyo S; Hafner R;
       Miro J; Aubertin J; Salamon R; Vilde JL; Service des Maladies
       Infectieuses et Tropicales, Hopital; Bichat-Claude Bernard, Universite
       Paris 7, France.
 SO    J Infect Dis. 1996 Jan;173(1):91-7. Unique Identifier : AIDSLINE
       MED/96132468
 AB    Pyrimethamine (50 mg) with folinic acid (15 mg) given three times weekly
       was assessed as primary prophylaxis for toxoplasmic encephalitis (TE) in
       554 human immunodeficiency virus-infected patients seropositive for
       Toxoplasma gondii and with < 200 CD4 cells/mm3. At 1 year, the incidence
       of TE was similar in pyrimethamine, 12%, and placebo, 13%, groups
       (relative risk [RR], 0.9; 95% confidence interval [CI], 0.6-1.4), and
       the survival rate was also similar, 85% and 80%, respectively (RR, 0.9;
       95% CI, 0.7-1.2). Rash was the only adverse event that appeared
       significantly more frequently in the pyrimethamine arm (7% vs. 1%). In
       the on-treatment analysis, the incidence of TE was lower in the
       pyrimethamine arm, 4%, than in the placebo arm, 12% (P < .006). Thus,
       pyrimethamine cannot be recommended as a first-line regimen for primary
       prophylaxis of TE if the patient can take cotrimoxazole. However, it
       should be considered for patients who are intolerant to cotrimoxazole,
       especially in high-risk patients with < 100 CD4 cells/mm3.
 DE    Adult  Animal  Anti-Infective Agents/ADVERSE EFFECTS/*THERAPEUTIC USE
       Antibodies, Protozoan/ANALYSIS  AIDS-Related Opportunistic
       Infections/MORTALITY/*PREVENTION &  CONTROL  Double-Blind Method  Drug
       Therapy, Combination  Encephalitis/MORTALITY/*PREVENTION & CONTROL
       Female  Follow-Up Studies  Human  Leucovorin/ADVERSE
       EFFECTS/*THERAPEUTIC USE  Male  Multivariate Analysis
       Pyrimethamine/ADVERSE EFFECTS/*THERAPEUTIC USE  Support, Non-U.S. Gov't
       Survival Rate  Toxoplasma/IMMUNOLOGY  Toxoplasmosis/COMPLICATIONS
       Toxoplasmosis, Cerebral/MORTALITY/*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).

