Medical and Economical Evaluation of New Diagnosis Tests of Mycobacterium Tuberculosis, Specific Immune Responses in HIV-infected Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible
排除标准
- •Confirmed TB disease No social right pregnancy
结局指标
主要结局
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.
时间窗: J0
次要结局
未报告次要终点