Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
This study has been completed.
Sponsor:
North Shore Long Island Jewish Health System
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00763295
First received: September 28, 2008
Last updated: October 25, 2012
Last verified: October 2012
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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.
Condition | Intervention |
---|---|
Latent Tuberculosis HIV Infections |
Other: T-Spot.TB test |
Study Type: | Observational |
Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Official Title: | Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV? |
Resource links provided by NLM:
Further study details as provided by North Shore Long Island Jewish Health System:
Enrollment: | 53 |
Study Start Date: | May 2008 |
Study Completion Date: | January 2010 |
Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
HIV infection |
Other: T-Spot.TB test
diagnostic test
|
![](https://webarchive.library.unt.edu/web/20130305101031im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
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
![](https://webarchive.library.unt.edu/web/20130305101031im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130305101031im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Jordan Glaser, MD, Staten Island University Hospital |
ClinicalTrials.gov Identifier: | NCT00763295 History of Changes |
Other Study ID Numbers: | 08-015 |
Study First Received: | September 28, 2008 |
Last Updated: | October 25, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by North Shore Long Island Jewish Health System:
latent tuberculosis HIV IFN-γ based assay |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013