Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00647205
First received: March 26, 2008
Last updated: August 8, 2011
Last verified: August 2011

March 26, 2008
August 8, 2011
January 2008
May 2010   (final data collection date for primary outcome measure)
Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB® [ Time Frame: 48 to 72 hours after the injection ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00647205 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
Evaluation of 2 Interferon γ Assays (QuantiFERON TB Gold In-Tube® and T-SPOT.TB®) in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube and T-SPOT.TB for the diagnosis of latent tuberculosis in this population. Concordance between TST, QuantiFERON TB Gold and T-SPOT.TB will be assessed in patients with different risks of TB, in a transversal study. This study will include 240 patients during 2 years: 80 HIV infected antiretroviral naïve patients originated from low TB prevalence countries, without any active TB (40 patients with CD4 cell count > 350/mm3, 40 with CD4 < 350/mm3), 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB. TST and the 2 blood interferon gamma assay will be compared according to the level of risk. The improvement of latent TB diagnosis in HIV infected patients may lead to the initiation of TB prophylaxis and decrease the incidence of this life threatening disease.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV Infections
  • Tuberculosis
  • Device: QuantiFERON TB Gold In-Tube
  • Device: T-SPOT.TB®
  • Sham Comparator: 1
    HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
    Interventions:
    • Device: QuantiFERON TB Gold In-Tube
    • Device: T-SPOT.TB®
  • Sham Comparator: 2
    HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)
    Interventions:
    • Device: QuantiFERON TB Gold In-Tube
    • Device: T-SPOT.TB®
  • Sham Comparator: 3
    HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)
    Interventions:
    • Device: QuantiFERON TB Gold In-Tube
    • Device: T-SPOT.TB®
  • Sham Comparator: 4
    HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)
    Interventions:
    • Device: QuantiFERON TB Gold In-Tube
    • Device: T-SPOT.TB®
  • Sham Comparator: 5
    HIV infected patients with active TB
    Interventions:
    • Device: QuantiFERON TB Gold In-Tube
    • Device: T-SPOT.TB®
  • Sham Comparator: 6
    HIV negative patients with active TB
    Interventions:
    • Device: QuantiFERON TB Gold In-Tube
    • Device: 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
240
November 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • sign an informed consent
  • to be adult
  • not to be pregnant
  • to have a clinical examination and a medical questionnaire

Exclusion Criteria:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00647205
ANRS EP 40 QUANTI SPOT
No
Marcia Trumeau regulatory, ANRS
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Daniel Bonnet, MD AP-HP Paris
Study Director: France Mentre, PHD AP-HP
French National Agency for Research on AIDS and Viral Hepatitis
August 2011

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