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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763295
First Posted: September 30, 2008
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northwell Health
September 28, 2008
September 30, 2008
October 26, 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.

Not Provided
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00763295
08-015
No
Not Provided
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Jordan Glaser, MD, Staten Island University Hospital
Northwell Health
Not Provided
Not Provided
Northwell Health
October 2012