Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-Infected Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

December 8, 2008

Last Updated Date

January 7, 2009

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the theoretical therapeutic impact (in terms of chimioprophylaxie antituberculeuse theoretically managed) of the tracking of tuberculosis-latent by QTF-TB Gold IT® or T-SPOT.TB among patients HIV. [ Time Frame: J0 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00805272 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-Infected Patients

Official Title ^ICMJE

Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-Infected Adults

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment

Condition ^ICMJE

HIV
Tuberculosis
Latent Tuberculosis Infection
HIV Infections

Intervention ^ICMJE

Other: QTF-TB Gold and T-SPOT TB

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: BOURGARIT Anne

01 42 49 97 64

anne.bourgarit@sls.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00805272

Responsible Party

LAFAYE Magali, Department Clinical Resarch of Developpement

Study ID Numbers ^ICMJE

P070311

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

BOURGARIT Anne

APHP

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP