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Completed

NCT Number: NCT02613169

Infant TB Infection Prevention Study

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

6 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kisumu County Hospital

Kisumu, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoniazid

Drug

HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.

Other names: INH

Primary outcomes

  1. Mycobacterium Tuberculosis (MTB) Infection

    Time frame: at 12 months post randomization

    Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status

  2. Mycobacterium Tuberculosis (MTB) Infection Cumulative Incidence

    Time frame: at 12 months post randomization

    Among HEU infants enrolled at approximately 6 weeks of age, compare the risk of acquiring MTB infection during 1 year of follow-up in infants randomized to receive INH vs. no INH using an interferon-gamma release (IGRA) QuantiFERON-TB Gold Plus (QFT-Plus) assay or tuberculin skin test as part of a composite endpoint to determine MTB infection status

Secondary outcomes

  1. Severe Adverse Events (SAE)

    Time frame: Over 12 months after randomization

    Number of infants with grade 3 or higher treatment-related adverse events as assessed by DAIDS Table for the Grading Severity of Pediatric Adverse Experiences

  2. Combined Outcome of MTB Infection, TB Disease, and Death

    Time frame: Over 12 months after randomization

    Number of infants with a combined endpoint of MTB infection, TB disease, and death

    • MTB infection as measured by IGRA or tuberculin skin test at 12 months post-enrollment
    • TB disease including microbiologically confirmed (culture or Xpert positive), or probable TB (clinical diagnosis).
    • Death of infant

  3. Combined Outcome of MTB Infection Including IGRA, TST, and Additional Interferon-gamma-independent Immune Markers in QFT-Plus Supernatants

    Time frame: Over 12 months after randomization

    Number of infants with MTB infection as measured by

    • IGRA, or
    • Tuberculin skin test (>10 mm) at 12 months post-enrollment, or
    • Interferon-gamma-independent immune markers in QFT-Plus supernatants

    Combined outcome will be defined as positive if IGRA OR TST OR interferon-gamma-independent marker is positive and combined outcome will be defined as negative if none of these is positive (if children do not have all three markers the definition will hold for available markers).

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants

Acronym: iTIPS

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Nov 24, 2015
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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