ACTRN12605000436673已完成3 期
A randomised mulitcentre trial of tenofovir (TDF) vs lamividine (LAM) vs TDF/LAM in antiretroviral naive subjects with HIV/HBV conifection over 48 weeks.
ational Centre in HIV Epidemiology and Clincial Research0 个研究点目标入组 36 人开始时间: 2005年9月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Written informed consent; Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA); 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 naive; 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, haemachromatosis, 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.
研究者
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