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

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:

MedlinePlus related topics: HIV/AIDS Rashes Tuberculosis

Drug Information available for: Interferon

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

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 (Adult, Senior)
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

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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	Assistance Publique - Hôpitaux de Paris

More Information


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:


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

ClinicalTrials.gov processed this record on September 23, 2016