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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00805272
Collaborator
(none)
536
Enrollment
1
Location
1
Arm
36
Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: QTF-TB Gold and T-SPOT TB
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
536 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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 Names:
  • IGRAVIH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de médecine interne hôpital saint louis Paris France 75018

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: BOURGARIT Anne, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT00805272
    Other Study ID Numbers:
    • P070311
    First Posted:
    Dec 9, 2008
    Last Update Posted:
    Mar 19, 2012
    Last Verified:
    Nov 1, 2008
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    HIV
    tuberculosis
    IGRA
    diagnosis
    treatment naive
    Additional relevant MeSH terms:
    Tuberculosis
    Latent Tuberculosis

    Study Results

    No Results Posted as of Mar 19, 2012