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

September 28, 2008
October 25, 2012
May 2008
January 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00763295 on ClinicalTrials.gov Archive Site
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Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Adult patients with HIV confirmed by standard methods

  • Latent Tuberculosis
  • HIV Infections
Other: T-Spot.TB test
diagnostic test
HIV infection
Intervention: Other: T-Spot.TB test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00763295
08-015
No
Jordan Glaser, MD, Staten Island University Hospital
North Shore Long Island Jewish Health System
Not Provided
Not Provided
North Shore Long Island Jewish Health System
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP