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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00805272
First received: December 8, 2008
Last updated: March 16, 2012
Last verified: November 2008

December 8, 2008
March 16, 2012
February 2009
September 2011   (final data collection date for primary outcome 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. [ Time Frame: J0 ] [ Designated as safety issue: Yes ]
To evaluate the theoretical therapeutic impact (in terms of chimioprophylaxie antituberculeuse theoretically managed) of the tracking of tuberculosis-latent by QTF-TB Gold IT® or T-SPOT.TB among patients HIV. [ Time Frame: J0 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00805272 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults

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

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV
  • Tuberculosis
  • Latent Tuberculosis Infection
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
Experimental: 1
Intervention: Other: QTF-TB Gold and T-SPOT TB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
536
February 2012
September 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00805272
P070311
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: BOURGARIT Anne APHP
Assistance Publique - Hôpitaux de Paris
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP