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

Not Applicable

Completed

• Conditions: HIV; Tuberculosis; Latent Tuberculosis Infection
• Interventions: Other: QTF-TB Gold and T-SPOT TB

• Registration Number: NCT00805272
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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

Study Timeline

• Status Verified: 2008-11
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Study Start: 2009-02
• Primary Completion: 2011-09
• Study Completion: 2012-02
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible

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Exclusion Criteria

Confirmed TB disease No social right pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	QTF-TB Gold and T-SPOT TB	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de médecine interne hôpital saint louis; 🇫🇷 Paris, France