Completed

NCT Number: NCT00805272

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

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

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Key information

Conditions

HIV Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Disease Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Latent Tuberculosis Infection Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de médecine interne hôpital saint louis

Paris, 75018, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QTF-TB Gold and T-SPOT TB

Other

evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients

Other names: IGRAVIH

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: IGRAVIH

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Dec 9, 2008
Registry last updated: Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed