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

NCT ID: NCT00647205

Last Updated: 2011-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count \> 350/mm3

Group Type SHAM_COMPARATOR

QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

2

HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 \< 350/mm3)

Group Type SHAM_COMPARATOR

QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

3

HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \< 350/mm3)

Group Type SHAM_COMPARATOR

QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

4

HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \> 350/mm3)

Group Type SHAM_COMPARATOR

QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

5

HIV infected patients with active TB

Group Type SHAM_COMPARATOR

QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

6

HIV negative patients with active TB

Group Type SHAM_COMPARATOR

QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

Interventions

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QuantiFERON TB Gold In-Tube

Intervention Type DEVICE

T-SPOT.TB®

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Responsible Party

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ANRS

Principal Investigators

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Daniel Bonnet, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP Paris

France Mentre, PHD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service des Maladies Infectieuses B Hopital Bichat

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ANRS EP 40 QUANTI SPOT

Identifier Type: -

Identifier Source: org_study_id

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