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

Phase 4

Completed

• Conditions: HIV Infections; Tuberculosis
• Interventions: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®

• Registration Number: NCT00647205
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary

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

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-31
• Primary Completion: 2010-05
• Study Completion: 2010-11
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	QuantiFERON TB Gold In-Tube	HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count \> 350/mm3
1	T-SPOT.TB®	HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count \> 350/mm3
2	QuantiFERON TB Gold In-Tube	HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 \< 350/mm3)
2	T-SPOT.TB®	HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 \< 350/mm3)
3	QuantiFERON TB Gold In-Tube	HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \< 350/mm3)
3	T-SPOT.TB®	HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \< 350/mm3)
4	QuantiFERON TB Gold In-Tube	HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \> 350/mm3)
4	T-SPOT.TB®	HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \> 350/mm3)
5	QuantiFERON TB Gold In-Tube	HIV infected patients with active TB
5	T-SPOT.TB®	HIV infected patients with active TB
6	QuantiFERON TB Gold In-Tube	HIV negative patients with active TB
6	T-SPOT.TB®	HIV negative patients with active TB

Primary Outcome Measures

Name	Time	Method
Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®	48 to 72 hours after the injection

Trial Locations

Locations (1)

Service des Maladies Infectieuses B Hopital Bichat; 🇫🇷 Paris, France