Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults

Conditions
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HIV, Tuberculosis, Latent Tuberculosis Infection

Intervention / Treatment
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* Other: QTF-TB Gold and T-SPOT TB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: QTF-TB Gold and T-SPOT TB<br>* evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients<br>* Other names: IGRAVIH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | J0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, tuberculosis, IGRA, diagnosis, treatment naive