Journal Article

Randomized Phase II Trial of Atovaquone with Pyrimethamine or Sulfadiazine for Treatment of Toxoplasmic Encephalitis in Patients with Acquired Immunodeficiency Syndrome: ACTG 237/ANRS 039 Study

Keith Chirgwin, Richard Hafner, Catherine Leport, Jack Remington, Janet Andersen, Elizabeth M. Bosler, Clemente Roque, Natasa Rajicic, Vincent McAuliffe, Philippe Morlat, D. T. Jayaweera, Jean-Louis Vilde and Benjamin J. Luft

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 34, issue 9, pages 1243-1250
Published in print May 2002 | ISSN: 1058-4838
Published online May 2002 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/339551
Randomized Phase II Trial of Atovaquone with Pyrimethamine or Sulfadiazine for Treatment of Toxoplasmic Encephalitis in Patients with Acquired Immunodeficiency Syndrome: ACTG 237/ANRS 039 Study

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In this international, noncomparative, randomized phase II trial, we evaluated the effectiveness and tolerance of atovaquone suspension (1500 mg orally twice daily) plus either pyrimethamine (75 mg per day after a 200-mg loading dose) or sulfadiazine (1500 mg 4 times daily) as treatment for acute disease (for 6 weeks) and as maintenance therapy (for 42 weeks) for toxoplasmic encephalitis (TE) in patients infected with human immunodeficiency virus. Twenty-one (75%) of 28 patients receiving pyrimethamine (95% lower confidence interval [CI], 58%) and 9 (82%) of 11 patients receiving sulfadiazine (95% lower CI, 53%) responded to treatment for acute disease. Of 20 patients in the maintenance phase, only 1 experienced relapse. Eleven (28%) of 40 eligible patients discontinued treatment as a result of adverse events, 9 because of nausea and vomiting or intolerance of the taste of the atovaquone suspension. Although gastrointestinal side effects were frequent, atovaquone-containing regimens are otherwise well tolerated and safe and may be useful for patients intolerant of standard regimens for toxoplasmic encephalitis.

Journal Article.  4942 words.  Illustrated.

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

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