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

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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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jordan Glaser, MD, Staten Island University Hospital
ClinicalTrials.gov Identifier: NCT00763295     History of Changes
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:
HIV Infections
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
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections