Latent TuberculosisNCT00763295
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
An observational study of Latent Tuberculosis and HIV Infections, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Latent Tuberculosis, HIV Infections
- What is being tested?
- T-Spot.TB test
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with HIV confirmed by standard methods
Who may be able to join
- adult individuals with confirmed HIV infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
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.
- Conditions
- Latent Tuberculosis, HIV Infections
- Being tested
- T-Spot.TB test
- Keywords
- latent tuberculosis, HIV, IFN-γ based assay
- Medical subject headings
- Latent Tuberculosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Spot.TB testOther
diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| HIV infection | Not described Receives: Other: T-Spot.TB test |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763295
- Sponsor's protocol ID
- 08-015
- Status last verified
- Oct 2012
- First submitted
- 28 Sep 2008
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
- ClinicalTrials.gov ID
- NCT00763295
- Acronym / sponsor ID
- 08-015
- Conditions
- Latent Tuberculosis, HIV Infections
- Keywords
- latent tuberculosis, HIV, IFN-γ based assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV infection | – | Other: T-Spot.TB test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with HIV confirmed by standard methods
Key inclusion criteria (1 listed)
- adult individuals with confirmed HIV infection
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Spot.TB testdiagnostic test | Other | HIV infection |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis and HIV Infections, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.