Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients (IGRAVIH)
Primary Purpose
HIV, Tuberculosis, Latent Tuberculosis Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QTF-TB Gold and T-SPOT TB
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV focused on measuring HIV, tuberculosis, IGRA, diagnosis, treatment naive
Eligibility Criteria
Inclusion Criteria:
18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible
Exclusion Criteria:
Confirmed TB disease No social right pregnancy
Sites / Locations
- Service de médecine interne hôpital saint louis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the theoretical therapeutic impact (in terms of CHIMIOPROPHYLAXIE antituberculous theoretically managed) of the tracking of tuberculosis-latent by QTF-TB Gold IT® or T-SPOT.TB among patients HIV.
Secondary Outcome Measures
Full Information
NCT ID
NCT00805272
First Posted
December 8, 2008
Last Updated
March 16, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00805272
Brief Title
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
Acronym
IGRAVIH
Official Title
Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tuberculosis is a current infection during HIV infection. After infectious contact, some patients will develop tuberculosis some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) which can reactivate later.In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in HIV-infected patients. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific po MTB infection are now sold but have not been evaluated in immunocompromised HIV-infected patients.
The primary endpoint of this study is the evaluation of the theoretic therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
Detailed Description
Principal outcome:
-Theoretic therapeutic impact evaluation of the use of IGRAS for diagnosis of LTBI in HIV-infected patients .
Secondary outcomes:
Medico-economic impact of replacement of TST by IGRAs in LTBI screening in HIV infected patients.
Concordance of IGRAs results with TST
Concordance between IGRAs.
Concordance between IGRAs in accordance to CD4 number(< 100, 100 à 200, 200 à 300, > à 300/mm3).
LTBI prevalence in the study group.
Effective consequences of tests results on therapeutic outcome of the patients LTBI criteria and therapeutic recommendations
One or 2 positive IGRAs test: LTBI recommended to be LTBI
1 negative IGRAs test and one undetermined : no LTBI
2 undetermined:
No clinical risk and negative TST: no diagnosis, eventually new test at 3 months or after HAART onset.
Clinical risk or TST> 10mm: LTBI recommended to be treated. Therapeutic outcome evaluation Effective consequences of IGRA's result on patients outcome at 6 months.
Analyzed criteria:
Therapeutic impact:
Patients percentage with different therapeutic outcome based on usual recommendations
Medico-economic impact
Medico-economic impact of both tests as early and late cost - efficacy
Statistics
Primary criteria:
Percentage of patients for whom therapeutic would have been changed by IGRAs results compared to usual diagnosis strategy.
Secondary criteria:
Concordance of IGRAs with TST
Concordance between both IGRAs.
Taille: 1000 patients
Timing:
-inclusions: 2 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Tuberculosis, Latent Tuberculosis Infection
Keywords
HIV, tuberculosis, IGRA, diagnosis, treatment naive
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
536 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
QTF-TB Gold and T-SPOT TB
Other Intervention Name(s)
IGRAVIH
Intervention Description
evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
Primary Outcome Measure Information:
Title
To evaluate the theoretical therapeutic impact (in terms of CHIMIOPROPHYLAXIE antituberculous theoretically managed) of the tracking of tuberculosis-latent by QTF-TB Gold IT® or T-SPOT.TB among patients HIV.
Time Frame
J0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible
Exclusion Criteria:
Confirmed TB disease No social right pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BOURGARIT Anne
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de médecine interne hôpital saint louis
City
Paris
ZIP/Postal Code
75018
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26213798
Citation
Bourgarit A, Baron G, Breton G, Tattevin P, Katlama C, Allavena C, Campa P, Ravaud P, Lortholary O, Carcelain G; IGRAVIH Study Group. Latent Tuberculosis Infection Screening and 2-Year Outcome in Antiretroviral-Naive HIV-Infected Patients in a Low-Prevalence Country. Ann Am Thorac Soc. 2015 Aug;12(8):1138-45. doi: 10.1513/AnnalsATS.201412-600OC. Erratum In: Ann Am Thorac Soc. 2016 Apr;13(4):576.
Results Reference
derived
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Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
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