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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 high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Sham Comparator | HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3 |
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| 2 | Sham Comparator | HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3) |
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| 3 | Sham Comparator | HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3) |
|
| 4 | Sham Comparator | HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3) |
|
| 5 | Sham Comparator | HIV infected patients with active TB |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuantiFERON TB Gold In-Tube | Device |
| ||
| T-SPOT.TB® |
| Measure | Description | Time Frame |
|---|---|---|
| Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB® | 48 to 72 hours after the injection |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Bonnet, MD | AP-HP Paris | Principal Investigator |
| France Mentre, PHD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service des Maladies Infectieuses B Hopital Bichat | Paris | 75018 | France |
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| 6 | Sham Comparator | HIV negative patients with active TB |
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| Device |
|
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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