Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) co-Infection and Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To investigate the efficacy and sustainability of HBV-active HAART on hepatitis B suppression by measuring changes in the HBV DNA levels as well as monitoring ALT levels, CD4 counts and HBV serology results.
研究概览
简要总结
Human immunodeficiency virus/Hepatitis B virus (HIV/HBV) co-infections are frequently observed due to shared routes of transmission, with reported figures indicating 6-9% of HIV-infected individuals in developed countries are chronically infected with HBV. HIV infection impacts on the natural progression of HBV infection, increasing levels of HBV replication and the risk of liver-associated mortality. Liver diseases associated with HBV are affected by the antiviral drugs used for HIV infection (toxic side effects), the current immune function in the patient, by improvements in the immune system brought about by control of the HIV infection, and by the development of resistance to the antiviral agents used for both the hepatitis B and the HIV infection. Co-infection with HBV increases the risk for hepatotoxicity in those individuals receiving highly active antiretroviral therapy (HAART) for their HIV infection.
This study will recruit patients who are co-infected with HIV and HBV, and are currently taking or who are about to commence HAART. The study cohort will include HIV-HBV co-infected individuals from the Alfred Hospital, the Royal Melbourne Hospital and high case load GP clinics who are referred to the Alfred Hospital.
The aim of the study is to investigate chronic hepatitis B and its impact on the progression of liver disease in HIV-infected persons receiving HAART.
This will be achieved by 6 monthly assessment with medical history, physical examination, bloods for markers of liver disease and hepatitis B activity and completion of questionnaires to measure adherence and alcohol use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 years of age and older
- •HIV positive
- •2 positive Hepatitis B surface antigen results 6 months apart
- •provision of informed consent
排除标准
- •unable to provide informed consent
结局指标
主要结局
To investigate the efficacy and sustainability of HBV-active HAART on hepatitis B suppression by measuring changes in the HBV DNA levels as well as monitoring ALT levels, CD4 counts and HBV serology results.
时间窗: 6 monthly assessment for 5 years
次要结局
- The surveillance of antiviral resistance mutations that may develop in those individuals who are unable to sustain hepatitis B suppression(6 monthly assessment for 5 years)
