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

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.
 
ClinicalTrials.gov Identifier: NCT00763295
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 26, 2012
Sponsor:
Information provided by:
Northwell Health

Study Description
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Brief Summary:

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 or disease Intervention/treatment
Latent Tuberculosis HIV Infections Other: T-Spot.TB test

Study Design
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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
Study Start Date : May 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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Groups and Cohorts
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Group/Cohort Intervention/treatment
HIV infection Other: T-Spot.TB test
diagnostic test


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763295


Locations
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United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
More Information
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Responsible Party: Jordan Glaser, MD, Staten Island University Hospital
ClinicalTrials.gov Identifier: NCT00763295    
Other Study ID Numbers: 08-015
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Keywords provided by Northwell Health:
latent tuberculosis
HIV
IFN-γ based assay
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Infections
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Latent Infection