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CompletedNCT00805272IGRAVIHUpdated Mar 19, 2012

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

An interventional study of QTF-TB Gold and T-SPOT TB in HIV, Tuberculosis and Latent Tuberculosis Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-19.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
536
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • HIV
  • Tuberculosis
  • Latent Tuberculosis Infection

Keywords

  • HIV
  • tuberculosis
  • IGRA
  • diagnosis
  • treatment naive
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 536 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Confirmed TB disease No social right pregnancy

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
536 participants (actual)

Study arms

  • Experimental
    1

    Other: QTF-TB Gold and T-SPOT TB

Interventions

  • OtherQTF-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

    Also known as: IGRAVIH

06

What researchers measure

Primary outcomes

  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.

    Time frame: J0

07

Study locations

1 site
  • Service de médecine interne hôpital saint louis
    Paris, 75018, France
08

References and documents

Publications

  • 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. Erratum In: Ann Am Thorac Soc. 2016 Apr;13(4):576. doi: 10.1513/AnnalsATS.134erratum1. PubMed 26213798 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00805272
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 9, 2008
Start date
Feb 2009
Primary completion
Sep 2011
Completion
Feb 2012
Last update
Mar 19, 2012

Study contacts

BOURGARIT Anne
principal investigator · APHP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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