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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. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039.
Clin Infect Dis 2002; 34(9):1243-50CI

Abstract

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.

Authors+Show Affiliations

Department of Medicine, State University of New York at Brooklyn, NY, USA. keith_chirgwin@merck.comNo 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)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

11941551

Citation

Chirgwin, Keith, et al. "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. AIDS Clinical Trials Group 237/Agence Nationale De Recherche Sur Le SIDA, Essai 039." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 34, no. 9, 2002, pp. 1243-50.
Chirgwin K, Hafner R, Leport C, et al. 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. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039. Clin Infect Dis. 2002;34(9):1243-50.
Chirgwin, K., Hafner, R., Leport, C., Remington, J., Andersen, J., Bosler, E. M., ... Luft, B. J. (2002). 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. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 34(9), pp. 1243-50.
Chirgwin K, et al. 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. AIDS Clinical Trials Group 237/Agence Nationale De Recherche Sur Le SIDA, Essai 039. Clin Infect Dis. 2002 May 1;34(9):1243-50. PubMed PMID: 11941551.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039. AU - Chirgwin,Keith, AU - Hafner,Richard, AU - Leport,Catherine, AU - Remington,Jack, AU - Andersen,Janet, AU - Bosler,Elizabeth M, AU - Roque,Clemente, AU - Rajicic,Natasa, AU - McAuliffe,Vincent, AU - Morlat,Philippe, AU - Jayaweera,D T, AU - Vilde,Jean-Louis, AU - Luft,Benjamin J, PY - 2002/4/10/pubmed PY - 2002/4/16/medline PY - 2002/4/10/entrez SP - 1243 EP - 50 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin. Infect. Dis. VL - 34 IS - 9 N2 - 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. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/11941551/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__AIDS_Clinical_Trials_Group_237/Agence_Nationale_de_Recherche_sur_le_SIDA_Essai_039_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/339551 DB - PRIME DP - Unbound Medicine ER -