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

NCT ID: NCT00763295

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Latent Tuberculosis HIV Infections

Keywords

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latent tuberculosis HIV IFN-γ based assay

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV infection

T-Spot.TB test

Intervention Type OTHER

diagnostic test

Interventions

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T-Spot.TB test

diagnostic test

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Staten Island University Hospital

Locations

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Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

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United States

Other Identifiers

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08-015

Identifier Type: -

Identifier Source: org_study_id