Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients (IGRAVIH)
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Purpose
Tuberculosis is a current infection during HIV infection. After infectious contact, some patients will develop tuberculosis some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) which can reactivate later.In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in HIV-infected patients. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific po MTB infection are now sold but have not been evaluated in immunocompromised HIV-infected patients.
The primary endpoint of this study is the evaluation of the theoretic therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
| Condition | Intervention |
|---|---|
|
HIV Tuberculosis Latent Tuberculosis Infection |
Other: QTF-TB Gold and T-SPOT TB |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults |
- To evaluate the theoretical therapeutic impact (in terms of CHIMIOPROPHYLAXIE antituberculous theoretically managed) of the tracking of tuberculosis-latent by QTF-TB Gold IT® or T-SPOT.TB among patients HIV. [ Time Frame: J0 ] [ Designated as safety issue: Yes ]
| Enrollment: | 536 |
| Study Start Date: | February 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Other: QTF-TB Gold and T-SPOT TB
evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
Other Name: IGRAVIH
|
Detailed Description:
Principal outcome:
-Theoretic therapeutic impact evaluation of the use of IGRAS for diagnosis of LTBI in HIV-infected patients .
Secondary outcomes:
- Medico-economic impact of replacement of TST by IGRAs in LTBI screening in HIV infected patients.
- Concordance of IGRAs results with TST
- Concordance between IGRAs.
- Concordance between IGRAs in accordance to CD4 number(< 100, 100 à 200, 200 à 300, > à 300/mm3).
- LTBI prevalence in the study group.
- Effective consequences of tests results on therapeutic outcome of the patients LTBI criteria and therapeutic recommendations
- One or 2 positive IGRAs test: LTBI recommended to be LTBI
- 1 negative IGRAs test and one undetermined : no LTBI
- 2 undetermined:
- No clinical risk and negative TST: no diagnosis, eventually new test at 3 months or after HAART onset.
- Clinical risk or TST> 10mm: LTBI recommended to be treated. Therapeutic outcome evaluation Effective consequences of IGRA's result on patients outcome at 6 months.
Analyzed criteria:
Therapeutic impact:
- Patients percentage with different therapeutic outcome based on usual recommendations
- Medico-economic impact
- Medico-economic impact of both tests as early and late cost - efficacy
- Statistics
Primary criteria:
- Percentage of patients for whom therapeutic would have been changed by IGRAs results compared to usual diagnosis strategy.
Secondary criteria:
- Concordance of IGRAs with TST
- Concordance between both IGRAs.
- Taille: 1000 patients
Timing:
-inclusions: 2 years
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible
Exclusion Criteria:
Confirmed TB disease No social right pregnancy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00805272 History of Changes |
| Other Study ID Numbers: | P070311 |
| Study First Received: | December 8, 2008 |
| Last Updated: | March 16, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
HIV tuberculosis IGRA diagnosis treatment naive |
Additional relevant MeSH terms:
|
Tuberculosis Latent Tuberculosis Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013