Medical and Economical Impact of IGRAs Diagnosis of Laten... | NCT00805272

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

NCT00805272

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Mar 19, 2012Estimated

Enrollment

536Actual

Phase

Not Applicable

Conditions

HIV
Tuberculosis
Latent Tuberculosis Infection

Interventions

QTF-TB Gold and T-SPOT TB

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2012

Last Update Posted Date

Mar 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

536Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Other: QTF-TB Gold and T-SPOT TB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	1

Outcomes Module

Primary Outcomes

Measure	Description	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.		J0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
BOURGARIT Anne	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de médecine interne hôpital saint louis		Paris	Paris	75018	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26213798	Derived	Bourgarit A, Baron G, Breton G, Tattevin P, Katlama C, Allavena C, Campa P, Ravaud P, Lortholary O, Carcelain G; IGRAVIH Study Group. Latent Tuberculosis Infection Screening and 2-Year Outcome in Antiretroviral-Naive HIV-Infected Patients in a Low-Prevalence Country. Ann Am Thorac Soc. 2015 Aug;12(8):1138-45. doi: 10.1513/AnnalsATS.201412-600OC.

ID	Term
D014376	Tuberculosis
D055985	Latent Tuberculosis
D004194	Disease

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections