Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
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ClinicalTrials.gov Identifier: NCT00647205 |
Recruitment Status
:
Completed
First Posted
: March 31, 2008
Last Update Posted
: August 9, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: 1
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
|
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® |
Sham Comparator: 2
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)
|
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® |
Sham Comparator: 3
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)
|
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® |
Sham Comparator: 4
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)
|
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® |
Sham Comparator: 5
HIV infected patients with active TB
|
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® |
Sham Comparator: 6
HIV negative patients with active TB
|
Device: QuantiFERON TB Gold In-Tube Device: T-SPOT.TB® |
- Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB® [ Time Frame: 48 to 72 hours after the injection ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- sign an informed consent
- to be adult
- not to be pregnant
- to have a clinical examination and a medical questionnaire
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647205
France | |
Service des Maladies Infectieuses B Hopital Bichat | |
Paris, France, 75018 |
Principal Investigator: | Daniel Bonnet, MD | AP-HP Paris | |
Study Director: | France Mentre, PHD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Marcia Trumeau regulatory, ANRS |
ClinicalTrials.gov Identifier: | NCT00647205 History of Changes |
Other Study ID Numbers: |
ANRS EP 40 QUANTI SPOT |
First Posted: | March 31, 2008 Key Record Dates |
Last Update Posted: | August 9, 2011 |
Last Verified: | August 2011 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Interferon, gamma HIV Infections Tuberculosis |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Latent Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Interferons Interferon-gamma Antineoplastic Agents Antiviral Agents Anti-Infective Agents |