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Interventions for Tuberculosis Control and Elimination 2002

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Two types of studies are available to test the hypothesis in human subjects<br />

that rifampicin with or without isoniazid is first, efficacious, <strong>and</strong> second,<br />

equivalent or better than isoniazid alone, even if given <strong>for</strong> shorter<br />

durations. The first type consists of comparisons of rifampicin <strong>and</strong><br />

rifampicin combinations with placebo, the second comparisons of rifampicin<br />

<strong>and</strong> rifampicin combinations with isoniazid (equivalence studies). The<br />

hypothesis <strong>and</strong> sample size requirements differ in the two approaches.<br />

Rifampicin <strong>and</strong> rifampicin combinations in comparison<br />

to placebo<br />

Studies comparing rifampicin (<strong>and</strong> combinations) with placebo have been<br />

carried out among patients with silicosis <strong>and</strong> patients with HIV infection<br />

(figure 87). 885,886,892<br />

In Kampala, Ug<strong>and</strong>a, two arms had rifampicin-containing regimens.<br />

Compared to placebo, daily rifampicin plus isoniazid <strong>for</strong> three months gave<br />

60% protection among tuberculin-positive patients with HIV infection.<br />

Rifampicin plus isoniazid plus pyrazinamide given daily <strong>for</strong> three months<br />

offered 49% protection. 886<br />

140<br />

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Figure 86. Mouse model of latent tuberculous infection <strong>and</strong> efficacy of various<br />

rifampicin combinations of preventive therapy on spleen bacillary count. Reproduced<br />

from 900 by the permission of the publisher American Thoracic Society at the American<br />

Lung Association.

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