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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
研究概览
简要总结
This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
- •Patients with Child-Pugh B or C cirrhosis
研究组 & 干预措施
1
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)
干预措施: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week (Drug)
1
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)
干预措施: Ribavirin (Copegus®) 1600 mg/day (Drug)
1
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week)
干预措施: Epoetin β (450 UI/kg/week) (Drug)
结局指标
主要结局
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
时间窗: 24 weeks after finishing treatment
次要结局
- Changes in serum HCV-RNA titers(between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment)
- Percentage of patients with serum HCV-RNA loads of < 50 IU/mL(at weeks 4, 8, 12, 24, and 48)