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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00647205
Other study ID # ANRS EP 40 QUANTI SPOT
Secondary ID
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


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
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