Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)
Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR
研究概览
详细说明
The proposed research consists of conducting a pilot trial "BKVIR" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients. As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. The initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy.
This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients. The data collected will constitute a unique database on this issue not only in France, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
Paris、法国、75015
- Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients ≥ 18 years
- Infected by HIV-1
- Naive to antiretroviral therapy
- Presenting an indication to start antiretroviral therapy (according to the recommendations of the Delfraissy 2004 report)
- Histologically or microbiologically confirmed tuberculosis
- Receiving tuberculostatic therapy for less than three months
Exclusion Criteria:
- Isolated HIV-2 infection
- Neoplasm treated by chemotherapy and/or radiotherapy
- Pregnancy or plans for pregnancy
- Breastfeeding
- Contraindication to one of the antiretroviral drugs
- Atypical mycobacterial infection
- Hemoglobin below 8 g/dL
- Neutrophils below 750/mm3
- Platelets below 50,000/mm3
- Creatinine clearance below 60 ml/min
- Alkaline phosphatase, ASAT, ALAT or bilirubin over 3 times the upper limit of normal
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
treatment success rate at week 48 (W48)
大体时间:W48
|
W48
|
次要结果测量
结果测量 |
大体时间 |
---|---|
course of plasma HIV-1 RNA between W0 and W48
大体时间:W48
|
W48
|
tuberculosis cure rate
大体时间:W48
|
W48
|
safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)
大体时间:W48
|
W48
|
frequency of treatment changes or discontinuations
大体时间:W48
|
W48
|
clinical progression of HIV infection
大体时间:W48
|
W48
|
course of CD4 and CD8 T lymphocytes
大体时间:W48
|
W48
|
study of resistance in the case of virological failure
大体时间:W48
|
W48
|
study of compliance and quality of life
大体时间:W48
|
W48
|
pharmacokinetic study of tuberculostatic agents
大体时间:W02,W08,W12, W24
|
W02,W08,W12, W24
|
effect of treatment on hepatitis B viral replication
大体时间:W48
|
W48
|
合作者和调查者
调查人员
- 首席研究员:Olivier Lortholary, MD、Hôpital Necker-Enfants Malades
- 研究主任:Geneviève Chêne, MD、INSERM U593
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- RNA 病毒感染
- 病毒病
- 血源性感染
- 传染病
- 性传播疾病,病毒
- 性病
- 慢病毒感染
- 逆转录病毒科感染
- 免疫缺陷综合症
- 免疫系统疾病
- 细菌感染
- 细菌感染和真菌病
- 革兰氏阳性细菌感染
- 放线菌感染
- 分枝杆菌感染
- 艾滋病毒感染
- 感染
- 结核
- 药理作用的分子机制
- 抗感染药
- 抗病毒药物
- 逆转录酶抑制剂
- 核酸合成抑制剂
- 酶抑制剂
- 抗艾滋病药物
- 抗逆转录病毒药物
- 细胞色素 P-450 酶抑制剂
- 细胞色素 P-450 酶诱导剂
- 细胞色素 P-450 CYP3A 诱导剂
- 细胞色素 P-450 CYP2B6 诱导剂
- 细胞色素 P-450 CYP2C9 抑制剂
- 细胞色素 P-450 CYP2C19 抑制剂
- 替诺福韦
- 恩曲他滨
- 依法韦仑
其他研究编号
- 2005-002470-30
- ANRS129 BKVIR
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
艾滋病毒感染的临床试验
-
Hospital Clinic of Barcelona完全的
-
Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
-
National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
-
AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
-
Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
-
Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
efavirenz的临床试验
-
University Medicine Greifswald完全的药代动力学 | 药效学 | 药物相互作用 | 肠转运体表达德国