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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647205
• Other study ID #: ANRS EP 40 QUANTI SPOT
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2008
• Last updated: August 8, 2011
• Start date: January 2008
• Est. completion date: November 2010

Study information

• Verified date: August 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV Infections
• Latent Tuberculosis
• Tuberculosis

Intervention

Device:
• QuantiFERON TB Gold In-Tube

• T-SPOT.TB®

Locations

Country	Name	City	State
France	Service des Maladies Infectieuses B Hopital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®		48 to 72 hours after the injection	Yes