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Hep Mec Cohort in Zambia (Hep Mec)

2026年5月9日 更新者：Michael Vinikoor、University of Alabama at Birmingham
Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

390

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。

学习联系方式

  • 姓名：Michael J Vinikoor, MD
  • 电话号码：205-934-5191
  • 邮箱：mjv3@uab.edu

研究联系人备份

学习地点

  • 赞比亚
      • Lusaka、赞比亚
        • 招聘中
        • University Teaching Hospital
        • 接触：
        • 接触：
      • Lusaka、赞比亚
        • 招聘中
        • Kanyama Level 1 Hospital
        • 接触：
        • 接触：
      • Lusaka、赞比亚
        • 招聘中
        • Matero Level 1 Hospital
        • 接触：
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This study will occur in Lusaka, Zambia, which has 12% adult HIV prevalence and ~4% adult HBsAg-positivity. Both HIV and HBV treatment are free and provided through the Ministry of Health. Tenofovir-based therapies are used for HBV monoinfection and HBV/HIV coinfection. Potential participants will be recruited from Ministry of Health (i.e., public sector) clinics at study sites including from a pool of participants in past HBV research projects. There are a 5 groups of participants we seek to enroll in the study, to facilitate addressing the scientific goals of the cohort.

描述

Inclusion Criteria:

Must meet the inclusion criteria for one of 5 groups, as follows:

  • Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped >1 year ago).
  • Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute/subacute onset of hepatitis signs and symptoms and ALT >10 times upper limit of normal
  • Group 3 (rx-naive hbv/hiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped >1 year ago).
  • Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive
  • Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay

Exclusion Criteria:

  • Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration

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
Treatment-naive chronic HBV monoinfection and eligible for antiviral therapy
Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy
Treatment-naive acute HBV monoinfection
Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis
Treatment-naive HBV/HIV coinfection
Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART
Treatment-experienced HBV/HIV coinfection with persistent HBsAg-emia
Adults with HBV/HIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART
Treatment-experienced HBV infection with HBsAg loss
Adults with and without HIV coinfection who have a documented history of chronic HBV infection that subsequently resolved (i.e., HBsAg loss) during antiviral therapy

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
Change in Intrahepatic Immune Cell Subset Frequencies
大体时间：Baseline and 1 year
Percentage of immune cell subsets (CD4+ T cells, CD8+ T cells, B cells, NK cells, Macrophages, and Neutrophils) among total liver immune cells as measured by single-cell RNA sequencing. Comparisons will be made between acute and chronic HBV infection, with and without HIV coinfection, and before and after nucleoside analog antiviral therapy.
Baseline and 1 year
Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss
大体时间：Baseline and 1 year
Count of genes showing differential expression (fold change ≥2.0, adjusted p-value <0.05) by single-cell RNA sequencing in liver biopsies from participants achieving HBsAg loss compared to those without HBsAg loss. Gene expression will be analyzed at baseline (predictive analysis), longitudinally (trajectory analysis), and at end of follow-up. Analysis will include comparison across acute vs. chronic HBV infection and with vs. without HIV coinfection.
Baseline and 1 year

次要结果测量

结果测量
措施说明
大体时间
HBV viral suppression
大体时间：Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
Reduction of HBV DNA in blood to below detectable levels
Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV viral suppression
大体时间：Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV RNA suppression in blood below the level of assay detection
Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
大体时间：Through study completion, an average of 5 years
Loss of hepatitis B surface antigen in blood samples
Through study completion, an average of 5 years
HBeAg seroconversion
大体时间：Through study completion, an average of 5 years
HBeAg-negativity in blood
Through study completion, an average of 5 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

University of Alabama at Birmingham

合作者

National Institute of Allergy and Infectious Diseases (NIAID)
Massachusetts General Hospital
Weill Medical College of Cornell University
Centre for Infectious Disease Research in Zambia
University of Zambia
Tropical Gastroenterology and Nutrition Group

调查人员

  • 首席研究员：Michael Vinikoor, MD、University of Alabama at Birmingham

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

有用的网址

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 (实际的)

2020年9月28日

初级完成 (估计的)

2029年8月31日

研究完成 (估计的)

2030年8月31日

研究注册日期

首次提交

2026年2月5日

首先提交符合 QC 标准的

2026年5月9日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月9日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-300003590
  • R37AI179640 (美国 NIH 拨款/合同)
  • R01AI147727 (美国 NIH 拨款/合同)
  • R01AI195435 (美国 NIH 拨款/合同)
  • 316-2019 (其他标识符：University of Zambia Biomedical Research Ethics Committee)

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

All study results and anonymized participant data will be made publicly-available. The timing will be based on when analysis is completed and results are disseminated. The study also will adhere to Zambian laws around data protection and sharing.

IPD 共享时间框架

Supporting information will be made available at study completion. IPD will be made available after completion of primary outcome analyses. We expect primary outcomes analyses will be completed in 2027, 2028, and 2029.

IPD 共享访问标准

During the study, only staff in Zambia and collaborating investigators will have access to IPD and supporting information. After the end of the study, this will be gradually made publicly available.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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