Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients (IGRAVIH)
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|ClinicalTrials.gov Identifier: NCT00805272|
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : March 19, 2012
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 or disease||Intervention/treatment||Phase|
|HIV Tuberculosis Latent Tuberculosis Infection||Other: QTF-TB Gold and T-SPOT TB||Not Applicable|
-Theoretic therapeutic impact evaluation of the use of IGRAS for diagnosis of LTBI in HIV-infected patients .
- 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.
- 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
- Percentage of patients for whom therapeutic would have been changed by IGRAs results compared to usual diagnosis strategy.
- Concordance of IGRAs with TST
- Concordance between both IGRAs.
- Taille: 1000 patients
-inclusions: 2 years
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||536 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||February 2012|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805272
|Service de médecine interne hôpital saint louis|
|Paris, France, 75018|
|Principal Investigator:||BOURGARIT Anne||APHP|