HIVIGRAVIHNCT00805272
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients
A study testing QTF-TB Gold and T-SPOT TB in people with HIV and Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Tuberculosis, Latent Tuberculosis Infection
- What is being tested?
- QTF-TB Gold and T-SPOT TB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible
Who cannot join
- Confirmed TB disease No social right pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine interne hôpital saint louis
Paris, Paris, 75018
About this study
Official title: Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
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
Read the 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
- Conditions
- HIV, Tuberculosis, Latent Tuberculosis Infection
- Being tested
- QTF-TB Gold and T-SPOT TB
- Keywords
- HIV, tuberculosis, IGRA, diagnosis, treatment naive
- Medical subject headings
- Tuberculosis, Latent Tuberculosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QTF-TB Gold and T-SPOT TBOther
Also called IGRAVIH
evaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: QTF-TB Gold and T-SPOT TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: J0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionSep 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOURGARIT Anne, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805272
- Sponsor's protocol ID
- P070311
- Acronym
- IGRAVIH
- Status last verified
- Nov 2008
- First submitted
- 8 Dec 2008
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26213798
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
- ClinicalTrials.gov ID
- NCT00805272
- Acronym / sponsor ID
- IGRAVIH / P070311
- Conditions
- HIV, Tuberculosis, Latent Tuberculosis Infection
- Keywords
- HIV, tuberculosis, IGRA, diagnosis, treatment naive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: QTF-TB Gold and T-SPOT TB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible
Key exclusion criteria (1 listed)
- Confirmed TB disease No social right pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QTF-TB Gold and T-SPOT TBAlso: IGRAVIHevaluation of the theoric therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients | Other | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Derived from this study: PubMed 26213798Bourgarit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOURGARIT Anne principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QTF-TB Gold and T-SPOT TB in people with HIV and Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.