此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

French HIV-HBV Cohort (COVViB)

2018年4月25日 更新者：Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Multi-center Study Evaluating Persistence of Hepatitis B Virus Replication, Long-term Prognostic Indicators and Their Clinical Relevance in Patients Co-infected With the Human Immunodeficiency Virus and Chronic Hepatitis B

The overarching purpose of this study is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.

研究概览

地位

未知

条件

干预/治疗

详细说明

The French HIV-HBV Cohort is an observational, non-interventional study including 308 HIV-infected patients with chronic HBV infection (HBsAg-positive serology >6 months) in seven clinical centers. Patients were recruited in 2002-2003 and followed prospectively every three to twelve months, during two phases, until 2010-2011. Extensive information on a variety of HIV- and HBV-related parameters were collected during these study visits.

This particular study aims to extend follow-up of the French HIV-HBV Cohort using a different type of design. Patients who completed at least one study phase of the French HIV-HBV Cohort are selected for participation. Patients continuing follow-up at a participating clinical center are asked to undergo their routine clinical visit, during which time medical data from the years since last cohort visit until their routine visit are extracted. For those who died, information from the years since last cohort visit until death will be collected.

The primary objective for this cohort extension is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.

The following secondary objectives are as follows:

  • To establish the extent of persistent viremia (PV) of HBV, quantified either in serum or within the hepatocyte
  • To understand whether this persistence effects clinically-relevant serological outcomes (i.e. HBeAg and HBsAg seroclearance and seroconversion along with HBsAg quantification) after prolonged follow-up
  • To quantify the evolution of liver fibrosis using non-invasive methods and, in a small subset of patients, liver biopsies, while investigating the virological and immunological factors associated with its progression and regression
  • To describe the causes of liver-related and non-liver-related morbidity and mortality and the direct effect of persistent HBV DNA replication on these outcomes

研究类型

观察性的

注册 (实际的)

152

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Lyon、法国、69317
        • Centre Hospitalier Universitaire de Lyon
      • Paris、法国、75012
        • Hôpital Saint-Antoine
      • Paris、法国、75020
        • Hopital Tenon
      • Paris、法国、75010
        • Hopital Saint-Louis

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

HIV-infected patients with chronic hepatitis B.

描述

Inclusion Criteria:

  • HBsAg seropositivity for >6 months (at initial cohort inclusion)
  • HIV-positive serology confirmed with Western blot (at initial cohort inclusion)
  • Karnofsky score >70 (at initial cohort inclusion)
  • Age ≥18 years old (at initial cohort inclusion)
  • Completed follow-up in at least one previous study phase of the French HIV-HBV Cohort
  • Obtained signed written informed consent

Exclusion Criteria:

  • Refusal to participate
  • Any severe physical, clinical or mental condition preventing participation

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
HIV-HBV co-infected individuals
No interventions will be administered. Individuals will be undergoing routine care.
其他：Routine care
Routine care recommended for patients co-infected with HIV and hepatitis B virus (per European Association for the Study of the Liver and European AIDS Clinical Society guidelines).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
HBV DNA replication
大体时间：14 years
Proportion of patients with detectable HBV DNA levels, as determined by a commercially-available PCR assay (>60 international units/mL), at the beginning and end of follow-up
14 years
HBeAg-seroclearance
大体时间：14 years
Proportion of hepatitis B "e" antigen (HBeAg)-positive patients who lose HBeAg-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up
14 years
HBsAg-seroclearance
大体时间：14 years
Proportion of patients who lose hepatitis B surface antigen (HBsAg)-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up
14 years
Liver fibrosis (FibroTest)
大体时间：14 years
Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroTest (non-invasive biochemical score) with a level >= 0.59, at the beginning and end of follow-up
14 years
Liver fibrosis (FibroScan)
大体时间：14 years
Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroScan (transient elastography) with a level >= 7.6 kPa, at the beginning and end of follow-up
14 years

次要结果测量

结果测量
措施说明
大体时间
Liver-related morbidity
大体时间：14 years
Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up
14 years
Liver-related mortality
大体时间：14 years
Proportion of patients who died due to liver-specific disease by the end of follow-up
14 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

合作者

ANRS, Emerging Infectious Diseases
Sidaction

调查人员

  • 首席研究员：Anders Boyd, MPH, PhD、INSERM UMR S 1136
  • 首席研究员：Karine Lacombe, MD, PhD、INSERM UMR S 1136

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年10月1日

初级完成 (实际的)

2018年3月31日

研究完成 (预期的)

2018年9月1日

研究注册日期

首次提交

2016年8月25日

首先提交符合 QC 标准的

2016年9月2日

首次发布 (估计)

2016年9月5日

研究记录更新

最后更新发布 (实际的)

2018年4月26日

上次提交的符合 QC 标准的更新

2018年4月25日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IMEA 49

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data will only be made available upon official request, pending approval by the Scientific Committee.

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.

Routine care的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Iran

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅