Infant TB Infection Prevention Study (iTIPS)

March 31, 2023 updated by: Grace John-Stewart, University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Kisumu County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isoniazid
Isoniazid (INH) ~10 mg/kg (7-15 mg/kg), will be administered once daily to infants in INH arm for 12 months.
Drug: Isoniazid
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
No Intervention: No Isoniazid
No INH will be administered to this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 12 months post randomization
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
at 12 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Over 12 months after randomization
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
Over 12 months after randomization
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).
Over 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Thrasher Research Fund

Investigators

  • Principal Investigator: Grace John-Stewart, MD, PhD, University of Washington, Dept of Global Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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