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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Purpose
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
|
Eligibility| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763295
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763295
Locations
| United States, New York | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
Sponsors and Collaborators
North Shore Long Island Jewish Health System
More Information
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:
|
Latent Tuberculosis Tuberculosis Actinomycetales Infections |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections |
ClinicalTrials.gov processed this record on February 27, 2015