TY - JOUR
T1 - Randomized phase II trial of atovaquone with pyrimethamine or sulfadiazine for treatment of toxoplasmic encephalitis in patients with acquired immunodeficiency syndrome
T2 - ACTG 237/ANRS 039 study
AU - AIDS Clinical Trials Group 237/Agence Nationale de Recherche sur le SIDA, Essai 039 Study Team
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 - Mc Auliffe, Vincent
AU - Morlat, Philippe
AU - Jayaweera, D. T.
AU - Vilde, Jean Louis
AU - Luft, Benjamin J.
AU - Sicard, Didier
AU - Jeantils, Vincent
AU - Dupont, Bertrand
AU - Raffi, Francois
AU - Eid, Zelina
AU - Dormant, Jean
AU - Bazin, Brigette
AU - Owens, Susan
AU - Walawander, Ann
AU - Rosenwald, Victoria
AU - Valentine, Fred
AU - Scerpella, Ernesto
AU - Rodriguez, Allan
AU - Smith, Donald
AU - Jordan, Patricia
AU - Wheat, L. Joseph
AU - Decker, Jean
AU - Shikuma, Cecilia
AU - Dobkin, Jay F.
AU - Mildvan, Donna
AU - Skahan, Kenneth
AU - Daniel, Pam
AU - Rogers, Michael
AU - Notario, Gerard
PY - 2002/5/1
Y1 - 2002/5/1
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.
AB - 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.
UR - https://www.scopus.com/pages/publications/0036569754
U2 - 10.1086/339551
DO - 10.1086/339551
M3 - Article
C2 - 11941551
AN - SCOPUS:0036569754
SN - 1058-4838
VL - 34
SP - 1243
EP - 1250
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 9
ER -