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

Study Overview
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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.

Official Title
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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

Conditions
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HIV Infections, Tuberculosis

Intervention / Treatment
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* Device: QuantiFERON TB Gold In-Tube
* Device: T-SPOT.TB®


Participation Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 1<br>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<br> <br> Device: T-SPOT.TB®<br> <br> |
| Sham Comparator: 2<br>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<br> <br> Device: T-SPOT.TB®<br> <br> |
| Sham Comparator: 3<br>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<br> <br> Device: T-SPOT.TB®<br> <br> |
| Sham Comparator: 4<br>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<br> <br> Device: T-SPOT.TB®<br> <br> |
| Sham Comparator: 5<br>HIV infected patients with active TB | Device: QuantiFERON TB Gold In-Tube<br> <br> Device: T-SPOT.TB®<br> <br> |
| Sham Comparator: 6<br>HIV negative patients with active TB | Device: QuantiFERON TB Gold In-Tube<br> <br> Device: T-SPOT.TB®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interferon, gamma, HIV Infections, Tuberculosis