Data monitoring experience in the AIDS toxoplasmic encephalitis study

James D. Neaton; Deborah N. Wentworth; Mark A. Jacobson

doi:10.1007/0-387-30107-0_31

Data monitoring experience in the AIDS toxoplasmic encephalitis study

James D. Neaton, Deborah N. Wentworth, Mark A. Jacobson

Biostatistics

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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.

Original language	English (US)
Title of host publication	Data Monitoring in Clinical Trials
Subtitle of host publication	A Case Studies Approach
Publisher	Springer US
Pages	320-329
Number of pages	10
ISBN (Print)	0387203303, 9780387203300
DOIs	https://doi.org/10.1007/0-387-30107-0_31
State	Published - 2006

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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.",

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Data monitoring experience in the AIDS toxoplasmic encephalitis study

Abstract

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