Stopped: Data Safety Monitoring Board (DSMB) recommended stopping study due to futility
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium tuberculosis (M.tb) to both adults and children. Children infected with TB have a higher risk of developing severe disease than adults with TB. The purpose of this study was to determine if the antibiotic isoniazid (INH) prevented TB infection in infants born to HIV-infected mothers.
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Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children
Timeframe: Through to week 96
Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children
Timeframe: Through to week 96