- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805272
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients (IGRAVIH)
Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75018
- Service de médecine interne hôpital saint louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
J0
|
Collaborators and Investigators
Investigators
- Principal Investigator: BOURGARIT Anne, APHP
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P070311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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