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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign an informed consent
- •to be adult
- •not to be pregnant
- •to have a clinical examination and a medical questionnaire
排除标准
- 未提供
研究组 & 干预措施
1
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
干预措施: T-SPOT.TB® (Device)
2
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)
干预措施: QuantiFERON TB Gold In-Tube (Device)
2
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 < 350/mm3)
干预措施: T-SPOT.TB® (Device)
3
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)
干预措施: QuantiFERON TB Gold In-Tube (Device)
3
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 < 350/mm3)
干预措施: T-SPOT.TB® (Device)
4
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)
干预措施: T-SPOT.TB® (Device)
4
HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 > 350/mm3)
干预措施: QuantiFERON TB Gold In-Tube (Device)
5
HIV infected patients with active TB
干预措施: QuantiFERON TB Gold In-Tube (Device)
5
HIV infected patients with active TB
干预措施: T-SPOT.TB® (Device)
6
HIV negative patients with active TB
干预措施: QuantiFERON TB Gold In-Tube (Device)
6
HIV negative patients with active TB
干预措施: T-SPOT.TB® (Device)
1
HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count > 350/mm3
干预措施: QuantiFERON TB Gold In-Tube (Device)
结局指标
主要结局
Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®
时间窗: 48 to 72 hours after the injection
次要结局
未报告次要终点