A Clinical Research on Functional Cure Strategies for Hepatitis B Among HIV/HBV Co-infected Patients in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hepatitis B surface antigen seroclearance
研究概览
简要总结
Evaluate the potential of ART combined with interferon therapy to achieve functional cure of hepatitis B in HIV/HBV co-infected patients
详细描述
This is a prospective, non-randomized, clinical observational cohort study. The subjects are the advantageous population for functional cure of hepatitis B in HIV/HBV co-infected patients . Depending on whether interferon therapy is used in the real world , the patients are divided into two groups: the ART combined with interferon group and the ART alone group, with 30 cases in each group. Hepatitis B surface antigen seroclearance rate and seroconversion rate will be observed during the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old, gender unrestricted.
- •Meeting the People's Republic of China Health Industry Standard (WS293-2008) - "AIDS and HIV Infection Diagnostic Criteria", confirmed as HIV-1 infected.
- •HBsAg positive for more than 6 months.
- •At least 1 year of ART treatment prior to screening, and currently undergoing ART treatment with HBsAg <1000IU/mL, HBeAg negative, HBV DNA <100IU/ml, CD4+T lymphocyte count >200 cells/μL and HIV-RNA<20 copies/ml.
排除标准
- •Pregnant, nursing, planning pregnancy, or with severe mental disorders or uncontrolled epilepsy.
- •Co-infected with Hepatitis A, C, D, or E viruses.
- •With other chronic liver diseases like autoimmune hepatitis, drug-induced hepatitis, alcoholic hepatitis, genetic metabolic liver diseases, or moderate to severe fatty liver.
- •With autoimmune diseases like rheumatoid arthritis, psoriasis, or lupus.
- •Post organ transplant, planning organ transplant, diagnosed or suspected of liver cancer or other malignant tumors, or undergoing immunosuppressive treatment.
- •With severe diseases of heart, lungs, kidneys, brain, retinal disorders, or uncontrolled hypertension or diabetes.
- •Excessive alcohol (average daily alcohol intake >40g for men, >20g for women) or drug users.
- •Participated in other interventional trials within the last three months, or other situations deemed inappropriate for inclusion by researchers.
研究组 & 干预措施
ART combined with interferon group
The treatment protocol is ART combined with pegylated interferon α-2b injection. The pegylated interferon α-2b injection is administered subcutaneously at a dose of 180ug once a week. Follow-up times are at baseline, and during treatment at weeks 4, 8, 12, 24, 36, 48, 60, and 72.
干预措施: Peginterferon alfa-2b Injection (Drug)
结局指标
主要结局
Hepatitis B surface antigen seroclearance
时间窗: 48 weeks
Hepatitis B surface antigen quantification less than 0.05 IU/mL.
次要结局
- Hepatitis B surface antigen seroconversion(48 weeks)
研究者
Linghua LI
Chief physician
Guangzhou 8th People's Hospital