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

NCT00647205 | Completed Phase 4

• 1 other identifier: ANRS EP 40 QUANTI SPOT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Tuberculosis

Keywords

Interferon, gamma; HIV Infections; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®

  48 to 72 hours after the injection

Study Arms (6)

1

SHAM COMPARATOR

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®

2

SHAM COMPARATOR

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®

3

SHAM COMPARATOR

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®

4

SHAM COMPARATOR

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®

5

SHAM COMPARATOR

HIV infected patients with active TB

Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®

6

SHAM COMPARATOR

HIV negative patients with active TB

Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®

Interventions

QuantiFERON TB Gold In-Tube DEVICE

1; 2; 3; 4; 5; 6

T-SPOT.TB® DEVICE

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service des Maladies Infectieuses B Hopital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

HIV Infections; Tuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Daniel Bonnet, MD

  AP-HP Paris

  PRINCIPAL INVESTIGATOR

• France Mentre, PHD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

FR (1)