Infant TB Infection Prevention Study (iTIPS)

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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)

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.

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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