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

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Case Western Reserve University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interferon-gamma; Interferons

Criteria

Inclusion Criteria:

• Age less than or equal to 5 years.

• Presence of written informed consent from the parent or legal guardian.

Exclusion Criteria:

• Children less than 3 months of age.

• Children that weigh less than 5 kg.

• Children that have laboratory-documented anemia (Hg < 9mg/dL).

• Children who are currently on antituberculosis therapy for TB disease.

• Informed consent is not obtained for all study procedures.

• Children will be excluded from primary data analysis if they are diagnosed with TB disease during follow-up.

• Enrollment will be deferred in children who have received live measles or polio vaccine within the past 6 weeks and children who have severe acute illness including acute upper or lower respiratory tract infection, acute diarrhea or central nervous system disease.