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Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?

This study has been completed.
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00763295
First received: September 28, 2008
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function.

Therefore, an accurate and reliable method for detection of latent tuberculosis in patients with HIV is urgently needed.

This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB,for detection of TB in HIV-infected individuals.


Condition Intervention
Latent Tuberculosis
HIV Infections
 Other: T-Spot.TB test

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Enrollment: 53
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV infection Other: T-Spot.TB test
diagnostic test

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with HIV confirmed by standard methods

Criteria

Inclusion Criteria

  • adult individuals with confirmed HIV infection

Exclusion Criteria:

  • Patients who are on INH treatment
  • Patients who have a positive PPD test within 1 year of study enrollment
  • Individuals with blistering or ulcerating skin disorder
  • Pregnant women
  • Patients who were given blood transfusion within 6 weeks prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763295

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: Jordan Glaser, MD, Staten Island University Hospital
ClinicalTrials.gov Identifier: NCT00763295     History of Changes
Other Study ID Numbers: 08-015
Study First Received: September 28, 2008
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
latent tuberculosis
HIV
IFN-γ based assay

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Latent Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on March 03, 2013