Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens
Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens
研究概览
地位
详细说明
The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.
The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.
The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Barcelona、西班牙、08003
- Hospital Del Mar
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Barcelona
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Badalona、Barcelona、西班牙、08916
- Hospital Germans Trías i Pujol
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV-infected patients coinfected with HCV genotypes 1 or 4
- Persistent transaminase elevation
- Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.
Exclusion Criteria:
- Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
- Patients with Child-Pugh B or C cirrhosis
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)
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Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
Ribavirin (Copegus®) 1600 mg/day
Epoetin β (450 UI/kg/week)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
大体时间：24 weeks after finishing treatment
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24 weeks after finishing treatment
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Changes in serum HCV-RNA titers
大体时间：between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
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between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
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Percentage of patients with serum HCV-RNA loads of < 50 IU/mL
大体时间：at weeks 4, 8, 12, 24, and 48
|
at weeks 4, 8, 12, 24, and 48
|
合作者和调查者
调查人员
- 首席研究员：Bonaventura Clotet, MD, PhD、Germans Trias i Pujol Hospital
- 首席研究员：Cristina Tural, MD, PhD、Germans Trias i Pujol Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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