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

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	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 HIV Infections	Other: QTF-TB Gold and T-SPOT TB

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-Infected Adults

Resource links provided by NLM:

MedlinePlus related topics: AIDS Tuberculosis

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	1000
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805272

Contacts

Contact: BOURGARIT Anne

01 42 49 97 64

anne.bourgarit@sls.aphp.fr

Locations

France
Service de médecine interne hôpital saint louis
Paris, France, 75018

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

BOURGARIT Anne

APHP

More Information

No publications provided

Responsible Party:	Department Clinical Resarch of Developpement ( LAFAYE Magali )
Study ID Numbers:	P070311
Study First Received:	December 8, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00805272 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

HIV
tuberculosis
IGRA
diagnosis
treatment naive

Study placed in the following topic categories:

Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Tuberculosis
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Actinomycetales Infections

Immunologic Deficiency Syndromes
Virus Diseases
Gram-Positive Bacterial Infections
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections
Tuberculosis
Retroviridae Infections

ClinicalTrials.gov processed this record on July 06, 2009