Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
NCT ID: NCT00805272
Last Updated: 2012-03-19
Study Results
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Basic Information
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COMPLETED
NA
536 participants
INTERVENTIONAL
2009-02-28
2012-02-29
Brief Summary
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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
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Detailed Description
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-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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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BOURGARIT Anne
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Service de médecine interne hôpital saint louis
Paris, Paris, France
Countries
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References
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Bourgarit A, Baron G, Breton G, Tattevin P, Katlama C, Allavena C, Campa P, Ravaud P, Lortholary O, Carcelain G; IGRAVIH Study Group. Latent Tuberculosis Infection Screening and 2-Year Outcome in Antiretroviral-Naive HIV-Infected Patients in a Low-Prevalence Country. Ann Am Thorac Soc. 2015 Aug;12(8):1138-45. doi: 10.1513/AnnalsATS.201412-600OC.
Other Identifiers
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P070311
Identifier Type: -
Identifier Source: org_study_id
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