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

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ClinicalTrials.gov Identifier: NCT00647205
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : August 9, 2011
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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®


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Assistance Publique - Hôpitaux de Paris
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Marcia Trumeau regulatory, ANRS
ClinicalTrials.gov Identifier: NCT00647205     History of Changes
Other Study ID Numbers: ANRS EP 40 QUANTI SPOT
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Latent Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents