P1041 (10047): 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 Study Restriction

Participants Off Study and Primary Analysis Completed


What is P1041?

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).

Study documents:

Sites where the study is implemented:

CRS ID Site Name City Country
No records returned.

Study contacts:

No records returned.

CTS: Anne Coletti


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.