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P1041 / Efficacy of Isoniazid to prevent TB

A Randomized Double Blind Placebo Controlled Trial to Determine the Efficacy of Isoniazid in preventing Tuberculosis Disease and Latent Tuberculosis Infection among Infants with Perinatal exposure to HIV

Study Status

Participants Off Study and Primary Analysis Completed

DAIDS Number

10047

IND Number

Non-IND

Summary

P1041 was a Phase II/III randomized, double-blind, placebo-controlled clinical research study of African infants exposed perinatally to HIV. The study was designed to determine the efficacy of isoniazid (INH) in preventing tuberculosis disease and latent tuberculosis infection. Thirteen hundred infants (age 3-4 months) were enrolled in this study, with INH or placebo provided for 96 weeks and follow-up continued for another 96 weeks thereafter (follow-up was completed in 2009).

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