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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

Primary Purpose

HIV Infections, Tuberculosis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
QuantiFERON TB Gold In-Tube
T-SPOT.TB®
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections focused on measuring Interferon, gamma, HIV Infections, Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Service des Maladies Infectieuses B Hopital Bichat

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Sham Comparator

Sham Comparator

Sham Comparator

Sham Comparator

Sham Comparator

Sham Comparator

Arm Label

1

2

3

4

5

6

Arm Description

HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3

HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)

HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)

HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)

HIV infected patients with active TB

HIV negative patients with active TB

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2008
Last Updated
August 8, 2011
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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1. Study Identification

Unique Protocol Identification Number
NCT00647205
Brief Title
Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tuberculosis
Keywords
Interferon, gamma, HIV Infections, Tuberculosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Sham Comparator
Arm Description
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
Arm Title
2
Arm Type
Sham Comparator
Arm Description
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)
Arm Title
3
Arm Type
Sham Comparator
Arm Description
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)
Arm Title
4
Arm Type
Sham Comparator
Arm Description
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)
Arm Title
5
Arm Type
Sham Comparator
Arm Description
HIV infected patients with active TB
Arm Title
6
Arm Type
Sham Comparator
Arm Description
HIV negative patients with active TB
Intervention Type
Device
Intervention Name(s)
QuantiFERON TB Gold In-Tube
Intervention Type
Device
Intervention Name(s)
T-SPOT.TB®
Primary Outcome Measure Information:
Title
Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®
Time Frame
48 to 72 hours after the injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Bonnet, MD
Organizational Affiliation
AP-HP Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
France Mentre, PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Service des Maladies Infectieuses B Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Learn more about this trial

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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