Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
研究概览
简要总结
The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)
详细描述
A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
- •Age 18 - 70 years
- •HBV DNA > 105 copies/ml
- •HBsAg positive >6 months or HBsAg positive and anti HB core IgM negative
- •Creatinine <= 2.0mg/dl (<= 0.2 mmol/L)
- •Platelet count >= 50,000/mm
- •HIV-1 antiretroviral therapy naïve
- •No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed
排除标准
- •HCV-RNA positive or Anti-HAV IgM positive
- •Acute hepatitis (serum ALT > 1000 U/L)
- •Active opportunistic infection
- •Other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
- •Concurrent malignancy requiring cytotoxic chemotherapy
- •Decompensated or Child's C cirrhosis
- •Alfa-fetoprotein (AFP) > 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
- •Pregnancy or lactation
- •Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
研究组 & 干预措施
Arm 1:
Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)
干预措施: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV) (Drug)
Arm 2
Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)
干预措施: Tenofovir (Drug)
Amr 3
Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)
干预措施: Tenofovir (Drug)
结局指标
主要结局
To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group
次要结局
- -HBV resistance at 48 weeks; -undetectable HBV DNA at weeks 12 & 24; -HBeAg and HBsAg seroconversion at weeks 24 & 48; -ALT chnages and rate of hepatic cytolysis; -HIV-1 RNA supression and CD4/CD8 changes over 48 weeks;