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

August 8, 2011 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS EP 40 QUANTI SPOT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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