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

This study has been completed.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00647205
First received: March 26, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
HIV Infections
Tuberculosis
Device: QuantiFERON TB Gold In-Tube
Device: T-SPOT.TB®
Phase 4

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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB® [ Time Frame: 48 to 72 hours after the injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2008
Study Completion Date: November 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
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 Device: T-SPOT.TB®
Sham Comparator: 2
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 Device: T-SPOT.TB®
Sham Comparator: 3
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 Device: T-SPOT.TB®
Sham Comparator: 4
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 Device: T-SPOT.TB®
Sham Comparator: 5
HIV infected patients with active TB
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB®
Sham Comparator: 6
HIV negative patients with active TB
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647205

Locations
France
Service des Maladies Infectieuses B Hopital Bichat
Paris, France, 75018
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Daniel Bonnet, MD AP-HP Paris
Study Director: France Mentre, PHD AP-HP
  More Information

No publications provided

Responsible Party: Marcia Trumeau regulatory, ANRS
ClinicalTrials.gov Identifier: NCT00647205     History of Changes
Other Study ID Numbers: ANRS EP 40 QUANTI SPOT
Study First Received: March 26, 2008
Last Updated: August 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Interferon, gamma
HIV Infections
Tuberculosis

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Latent Tuberculosis
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014