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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by (Responsible Party): | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00805272 |
Purpose
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
| Condition | Intervention |
|---|---|
|
HIV Tuberculosis Latent Tuberculosis Infection |
Other: QTF-TB Gold and T-SPOT TB |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults |
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Other: QTF-TB Gold and T-SPOT TB
evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
Other Name: IGRAVIH
|
Principal outcome:
-Theoretic therapeutic impact evaluation of the use of IGRAS for diagnosis of LTBI in HIV-infected patients .
Secondary outcomes:
Analyzed criteria:
Therapeutic impact:
Primary criteria:
Secondary criteria:
Timing:
-inclusions: 2 years
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: BOURGARIT Anne | +33 (0)1 42 49 97 64 | anne.bourgarit@sls.aphp.fr |
| France | |
| Service de médecine interne hôpital saint louis | Recruiting |
| Paris, France, 75018 | |
| Contact: BOURGARIT Anne +33 (0)1 42 49 97 64 anne.bourgarit@sls.aphp.fr | |
| Contact: CARCELAIN Guislaine +33 (0) 1 42 17 74 94 guislaine.carcelain@psl.aphp.fr | |
| Principal Investigator: | BOURGARIT Anne | APHP |
More Information
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00805272 History of Changes |
| Other Study ID Numbers: | P070311 |
| Study First Received: | December 8, 2008 |
| Last Updated: | January 9, 2012 |
| Health Authority: | France: Ministry of Health |
|
HIV tuberculosis IGRA diagnosis treatment naive |
|
Tuberculosis Latent Tuberculosis Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |