Infant TB Infection Prevention Study

Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants

Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.

The purpose of this trial is to determine whether isoniazid (INH) reduces the risk of Mycobacterium tuberculosis (MTB) infection in HIV-exposed but uninfected (HEU) children, as well as to determine epidemiologic and immunologic correlates of MTB infection in HEU.

Inclusion Criteria:

• HIV exposed infants
• Aged 6 weeks within (+ 4 weeks)
• Born to HIV-infected mothers
• Not premature and over 2.5 kg

Exclusion Criteria:

• Infants with known exposure to active TB in household
• Premature and < 2.5 kg