Diagnosis of Tuberculosis Infection in HIV Co-infected Children

NCT00541294 | Completed

• 1 other identifier: RES104272
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival. The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited. Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children:

1. 1.assess the agreement between the TST and blood-based diagnostic testing,
2. 2.compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
3. 3.measure the impact of age, nutritional and immune status on children's response to blood-based testing,
4. 4.describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB.

Conditions

Latent Tuberculosis Infection; Tuberculosis; HIV Infections

Keywords

Tuberculosis; HIV; Diagnostics; Pediatrics

Study Arms (2)

B

M.tb unexposed HIV-infected and uninfected children \<15 years of age

A

M.tb exposed HIV-infected and uninfected children \<15 years of age

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

HIV seropositive and seronegative South African children (6months to 15years) with and without M.tb exposure

You may qualify if:

• age less than 15 years
• completion of informed consent

You may not qualify if:

• less than 3 months of age
• documented anemia
• recent diagnosis of tuberculosis
• receiving treatment for tuberculosis

Sponsors & Collaborators

• Case Western Reserve University: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Despond TuTu TB Centre, Stellenbosch University

Tygerberg, Western Cape, 07505, South Africa

Location

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis; HIV Infections

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Anna M Mandalakas, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Anneke C Hesseling, MD, MS

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: January 15, 2008
• Primary Completion: February 22, 2011
• Study Completion: February 22, 2011
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

ZA (1)