Infant TB Infection Prevention Study (iTIPS)

University of Washington

Status and phase: Completed; Phase 2

Conditions: Tuberculosis

Treatments: Drug: Isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT02613169

STUDY00000341

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 6 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Isoniazid

Experimental group

Description:

Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.

Treatment:

Drug: Isoniazid

No Isoniazid

No Intervention group

Description:

No INH will be administered to this arm.