A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 415
- 主要终点
- Sustained Virological Response (SVR)
研究概览
简要总结
This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, ≥18 years of age
- •CHC genotype 1
- •Stable HIV-1 infection
排除标准
- •Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors
- •Medical condition associated with liver disease other than CHC infection
研究组 & 干预措施
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg
干预措施: Peginterferon alfa-2a (Drug)
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg
干预措施: Ribavirin (Drug)
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
干预措施: Peginterferon alfa-2a (Drug)
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Virological Response (SVR)
时间窗: Week 72
SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA \< 20 IU/mL measured ≥ Day 477 \[≥ Week 68\]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
时间窗: Up to Week 72
Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
次要结局
- Virological Response at End of Treatment Period(Week 48)
- Virological Response at Weeks 4, 12 and 24(Weeks 4, 12 and 24)
- Relapse of Virological Response(Weeks 48 and 72)
- Rapid Virological Response (RVR) by Week 4(Week 4)
- Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12(Week 12)