Clinical Trials

MainTitle

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
French National Agency for Research on AIDS and Viral Hepatitis


Information provided by (Responsible Party)
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
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections
Tuberculosis

Device : QuantiFERON TB Gold In-Tube
Device : T-SPOT.TB®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

  • Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB® [ Time Frame: 48 to 72 hours after the injection ]

Enrollment: 240
Study Start Date: January 2008
Study Completion Date: November 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Sham Comparator: 1
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
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)
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)
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)
Device: QuantiFERON TB Gold In-Tube
Device: T-SPOT.TB®
Sham Comparator: 5
HIV infected patients with active TB
Device: QuantiFERON TB Gold In-Tube
Device: T-SPOT.TB®
Sham Comparator: 6
HIV negative patients with active TB
Device: QuantiFERON TB Gold In-Tube
Device: T-SPOT.TB®

Detailed Description:

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.

Eligibility

Eligibility

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

Criteria

Inclusion Criteria:

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


Exclusion Criteria:

contacts and locations

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00647205

Locations

France
Service des Maladies Infectieuses B Hopital Bichat
Paris, France, 75018

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator: Daniel Bonnet, MD AP-HP Paris
Study Director: France Mentre, PHD Assistance Publique - Hôpitaux de Paris
More Information

More Information


Responsible Party: Marcia Trumeau regulatory, ANRS  
ClinicalTrials.gov Identifier: NCT00647205   History of Changes  
Other Study ID Numbers: ANRS EP 40 QUANTI SPOT  
Study First Received: March 26, 2008  
Last Updated: August 8, 2011  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Interferon, gamma
HIV Infections
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
HIV Infections

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.