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NCT00763295 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00763295
Other study ID # 08-015
Secondary ID
Status Completed
Phase N/A
First received September 28, 2008
Last updated October 25, 2012
Start date May 2008
Est. completion date January 2010

Study information
Verified date October 2012
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• T-Spot.TB test
diagnostic test

Locations
Country Name City State
United States Staten Island University Hospital Staten Island New York

Sponsors (1)
Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

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