A double-blind, placebo-controlled trial was set up to compare clindamycin and pyrimethamine as prophylaxis for toxoplasmic encephalitis (TE) in HIV-infected patients at risk of the disorder. Interim analysis showed that clindamycin-treated patients were 4·4 (95% confidence interval 1 ·3-15·2) times more likely to experience an adverse effect that necessitated withdrawal of the study drug than those who received placebo. Diarrhoea and rash were reported in 16 (31%) and 11(21%), respectively, of 52 patients treated with clindamycin (300 mg twice daily) compared with 2 (6%; p=0·06) and none (p=0·01) of the 32 placebo-treated patients. The clindamycin arm of the trial was prematurely terminated, although recruitment to the pyrimethamine arm continues.
Bibliographical noteFunding Information:
substantially greater than that acceptable with a prophylactic regimen, especially for patients who require many other drugs. Clindamycin is also effective in treatment of P carinii pneumonia and has been suggested as a possible prophylactic agent in patients at high risk of this common AIDS-associated opportunistic infection.8 The population we studied was at high risk of P carinii pneumonia as well as TE; our findings therefore suggest that clindamycin would also be poorly tolerated as a prophylactic regimen for that disorder. Pyrimethamine cannot be recommended for prophylaxis against TE simply on the basis that clindamycin will not do. The pyrimethamine arm of our trial continues. This study was supported by a contract from the National Institute of Allergy and Infectious Diseases. We thank Dr J. Neaton, Mr J. Gerard, Dr S. Milwee, Dr W. Rida, Dr D. C. Wright, Dr M. Carlyn, Dr S. Slome, and Dr B. Fireman for their help in completing this study. Community Programs for Clinical Research on AIDS: Bronx-Lebanon Hospital Centre (Dr J. A. Ernst, Dr 1. Grant, Dr C. Fornilda); Community Consortium (Dr C. L. Brosgart, Dr W. J. Fessel, Dr W. F. Owen); Henry Ford Hospital (Dr E. Fisher, Dr N. Markowitz, Dr L. Saravolatz); North Jersey Community Research Initiative (Ms H. Brown, Ms V. Taylor); AIDSS Research Consortium of Atlanta, Inc (Dr C. Lopez, Dr M. Tanner); Research and Education Group (Ms C. Salveson, Dr J. H. Sampson); Comprehensive AIDS Alliance of Detroit (Dr L. Crane); Hill Health Corporation (Dr S-H. Lam); Chicago Community Program for Clinical Research on AIDS (Dr R. Luskin-Hawk); Delaware Community Program for Clinical Research on AIDS (Dr W. J. Holloway); Richmond AIDS Consortium (Mr R. T. Higginson); Louisiana Community AIDS Research Program (Dr J. Osterberger); Harlem AIDS Treatment Group (Ms L. Macey); Denver Community Program for Clinical Research on AIDS (Ms C. Mesard); Clinical Directors Network of Region II (Dr T. Meyers); Addition Research and Treatment Corporation (Dr J. Rawls).
Copyright 2019 Elsevier B.V., All rights reserved.