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

HIV Clinical Trial

— IGRAVIH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805272
• Other study ID #: P070311
• Status: Completed
• Phase: N/A
• First received: December 8, 2008
• Last updated: March 16, 2012
• Start date: February 2009
• Est. completion date: February 2012

Study information

• Verified date: November 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: February 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
France	Service de médecine interne hôpital saint louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes