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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 4

Conditions: Tuberculosis; HIV Infections

Treatments: Device: T-SPOT.TB®; Device: QuantiFERON TB Gold In-Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT00647205

ANRS EP 40 QUANTI SPOT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 6 patient groups

1

Sham Comparator group

Description:

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

Treatment:

Device: T-SPOT.TB®

Device: QuantiFERON TB Gold In-Tube

2

Sham Comparator group

Description:

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

Treatment:

Device: T-SPOT.TB®

Device: QuantiFERON TB Gold In-Tube

3

Sham Comparator group

Description:

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

Treatment:

Device: T-SPOT.TB®

Device: QuantiFERON TB Gold In-Tube

4

Sham Comparator group

Description:

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

Treatment:

Device: T-SPOT.TB®

Device: QuantiFERON TB Gold In-Tube

5

Sham Comparator group

Description:

HIV infected patients with active TB

Treatment:

Device: T-SPOT.TB®

Device: QuantiFERON TB Gold In-Tube

6

Sham Comparator group

Description:

HIV negative patients with active TB

Treatment:

Device: T-SPOT.TB®

Device: QuantiFERON TB Gold In-Tube