Clinical trial NCT00805272: Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
Official title: Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Tuberculosis
Latent Tuberculosis Infection
Keywords: HIV
tuberculosis
IGRA
diagnosis
treatment naive
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: J0
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de médecine interne hôpital saint louis
Study officials:
affiliation: APHP
name: BOURGARIT Anne
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.