HIV InfectionsPhase 4NCT00647205

Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

A Phase 4 study testing QuantiFERON TB Gold In-Tube and T-SPOT.TB® in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Tuberculosis
What is being tested?: QuantiFERON TB Gold In-Tube and T-SPOT.TB®
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 1 siteFrance
Study dates: Jan 2008to Nov 2010
Phase: Phase 4
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

sign an informed consent
to be adult
not to be pregnant
to have a clinical examination and a medical questionnaire

Who cannot join

Trial locations and contacts

1 site in 1 country.

France1 site

Service des Maladies Infectieuses B Hopital Bichat
Paris, 75018

Other trials in France

About this study

Official title: Evaluation of 2 Interferon γ Assays (QuantiFERON TB Gold In-Tube® and T-SPOT.TB®) in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

Read the detailed description

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube and T-SPOT.TB for the diagnosis of latent tuberculosis in this population. Concordance between TST, QuantiFERON TB Gold and T-SPOT.TB will be assessed in patients with different risks of TB, in a transversal study. This study will include 240 patients during 2 years: 80 HIV infected antiretroviral naïve patients originated from low TB prevalence countries, without any active TB (40 patients with CD4 cell count > 350/mm3, 40 with CD4 < 350/mm3), 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB. TST and the 2 blood interferon gamma assay will be compared according to the level of risk. The improvement of latent TB diagnosis in HIV infected patients may lead to the initiation of TB prophylaxis and decrease the incidence of this life threatening disease.

Conditions: HIV Infections, Tuberculosis
Being tested: QuantiFERON TB Gold In-Tube, T-SPOT.TB®
Keywords: Interferon, gamma, HIV Infections, Tuberculosis
Medical subject headings: HIV Infections, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QuantiFERON TB Gold In-TubeDevice
T-SPOT.TB®Device

Study groups in NCT00647205
Study group	Role	What they receive
1	Sham comparator	HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3 Receives: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®
2	Sham comparator	HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3) Receives: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®
3	Sham comparator	HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3) Receives: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®
4	Sham comparator	HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3) Receives: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®
5	Sham comparator	HIV infected patients with active TB Receives: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®
6	Sham comparator	HIV negative patients with active TB Receives: Device: QuantiFERON TB Gold In-Tube; Device: T-SPOT.TB®

What is being measured

The primary outcome is the main question the study is designed to answer.

Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®
Measured: 48 to 72 hours after the injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Nov 2010

First posted31 Mar 2008 (estimated)
Study startJan 2008
Primary completionMay 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
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 4
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00647205
Sponsor's protocol ID: ANRS EP 40 QUANTI SPOT
Status last verified: Aug 2011
First submitted: 26 Mar 2008
Last updated: 9 Aug 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of 2 Interferon γ Assays (QuantiFERON TB Gold In-Tube® and T-SPOT.TB®) in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
ClinicalTrials.gov ID: NCT00647205
Acronym / sponsor ID: ANRS EP 40 QUANTI SPOT
Conditions: HIV Infections, Tuberculosis
Keywords: Interferon, gamma, HIV Infections, Tuberculosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (estimated)
Lead sponsor: French National Agency for Research on AIDS and Viral HepatitisOther government
Study start: Jan 2008
Primary completion: May 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 31 Mar 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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
1	Sham comparator	Device: QuantiFERON TB Gold In-Tube, Device: T-SPOT.TB®HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
2	Sham comparator	Device: QuantiFERON TB Gold In-Tube, Device: T-SPOT.TB®HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)
3	Sham comparator	Device: QuantiFERON TB Gold In-Tube, Device: T-SPOT.TB®HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)
4	Sham comparator	Device: QuantiFERON TB Gold In-Tube, Device: T-SPOT.TB®HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)
5	Sham comparator	Device: QuantiFERON TB Gold In-Tube, Device: T-SPOT.TB®HIV infected patients with active TB
6	Sham comparator	Device: QuantiFERON TB Gold In-Tube, Device: T-SPOT.TB®HIV negative patients with active TB

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

sign an informed consent
to be adult
not to be pregnant
to have a clinical examination and a medical questionnaire

Key exclusion criteria (1 listed)

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
QuantiFERON TB Gold In-Tube	Device	1, 2, 3, 4, 5, 6
T-SPOT.TB®	Device	1, 2, 3, 4, 5, 6

Primary outcome

Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®
Time frame: 48 to 72 hours after the injection

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 9 Aug 2011.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

Daniel Bonnet, MD principal investigator

AP-HP Paris

France Mentre, PHD study director

Assistance Publique - Hôpitaux de Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 9 Aug 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB® (time frame: 48 to 72 hours after the injection). 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 NCT00647205.

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 9 Aug 2011.