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Interferon-Gamma Release Assays in Tuberculosis (TB) - HIV Co-infected Children

NCT00604617 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 564

Last updated 2022-01-18

No results posted yet for this study

Summary

Tuberculosis (TB) is a disease affecting the lungs that is caused by a germ spread by coughing. TB infection is currently diagnosed by a skin test that has limited accuracy. The purpose of this study is to look at the reliability of a new blood test for diagnosing TB infection in children. Study participants will include 300 HIV-infected (HIV infection is a viral infection that causes disease which destroys the body's ability to protect itself from infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years, residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province, South Africa. Study procedures will include questionnaires, HIV and TB testing, which will be performed by blood and skin tests. Participants may be involved in study related procedures for up to 24 months.

Conditions

Interventions

PROCEDURE

Interferon-Gamma Release Assay

IGRAs

DRUG

RT-23

TST - tuberculin skin test

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Case Western Reserve University

    lead OTHER

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-26
Primary Completion
2012-08-21
Completion
2012-08-21

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00604617 on ClinicalTrials.gov