Abstract
The toxoplasmic encephalitis (TOXO) study was designed to determine whether primary prophylaxis with pyrimethamine (25 mg thrice weekly) or clinidamycin (300 mg twice daily) would reduce the incidence of toxoplasmic encephalitis (TE) among HIV-infected patients considered at risk for the opportunistic infection. Using a modified double-blind design, patients were randomized to clindamycin or matching placbo (2 : 1) or to pyrimethamine or matching placebo (2 : 1). The clindamycin arm of the study was terminated after a median follow-up of three months due to dose-limiting toxcities; the pyrimethamine arm was terminated after a median follow-up of eight months due to a very low TE event rate in the placebo and pyrimethamine groups and a higher death rate among patients assigned pyrimethamine.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Luft BJ, Remington JS. 1992. Toxoplasmic encephalitis in AIDS. Clin Infect Dis 15:211–222.
Jones JL, Hanson DL, Dworkin MS, Alderton DL, Fleming PL, Kaplan JE, Ward J. 1999. Surveillance for AIDS-defining opportunistic illnesses, 1992–1997. Morbidity & Mortality Weekly Report. CDC Surveillance Summaries 48(2):1–22.
Neaton JD, Wentworth DN, Rhame F, Hogan C, Abrams DI, Deyton L. 1994. Considerations in choice of a clinical endpoint for AIDS clinical trials. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Stat Med 13:2107–2125.
Luft BJ, Remington JS: Toxoplasmosis of the central nervous system. 1985. In Remington JS, Swartz MN (eds.): Current Clinical Topics in Infectious Disease Vol 6., pp. 315–358, McGraw Hill, New York.
Haybittle JL. 1971. Repeated assessment of results in clinical trials of cancer treatments. Br J of Radiol 44:793–797.
DeMets DL, Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, et al. 1995. The Data and Safety Monitoring Board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 16:408–421.
Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, et al. 1992. Toxicity of clindamycin as prophylaxis for AIDS-associated toxoplasmic encephalitis. Lancet 339:333–334.
Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, et al. 1994. Primary prophylaxis with pyrimethamine for toxoplasmic encephalitis in patients with advanced human immunodeficiency virus disease: results of a randomized trial. J Infect Dis 169:384–394.
Hardy WD, Feinberg J, Finkelstein DM, Power ME, He W, Kaczka C, et al. 1992. A controlled trial of trimethoprim-sulfamethoxazole ir aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in pateints with the acquired immunodeficiency syndrome. N Engl J Med 27:1842–1848.
Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monitoring committees. www.fda.gov/cber/gdlns/clindatmon.htm
Carr A, Tindall B, Brew BJ, Marriott DJ, Harkness JL, Penny R, Cooper DA. 1992. Low-dose trimethoprim-sulfamethoxazole prophylaxis for toxoplasmic encephalitis in patients with AIDS. Ann Intern Med 117:106–111.
Bozzette SA, Finkelstein DM, Spector SA, Frame P, Powderly WG, He W, et al. 1995. A randomized trial of three antipneumocystis agents in patients with advanced immunodeficiency virus infection N Engl J Med 332:693–699.
Masur H, Kaplan JE, Holmes KK. 2002. Guidelines for preventing opportunistic infections among HIV-infected persons-2002. Recommendations of the U.S. Public Health Service and the Infectious Diseases Society of America. Ann Intern Med 137:435–478.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2006 Springer Science+Business Media, Inc.
About this chapter
Cite this chapter
Neaton, J.D., Wentworth, D.N., Jacobson, M.A. (2006). Data Monitoring Experience in the AIDS Toxoplasmic Encephalitis Study. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_31
Download citation
DOI: https://doi.org/10.1007/0-387-30107-0_31
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-20330-0
Online ISBN: 978-0-387-30107-5
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)