A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
研究概览
简要总结
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, genotype 1, hepatitis C with detectable HCV RNA
- •HIV-1 infection for >6 months
- •Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis)
排除标准
- •Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- •Previous treatment with interferon or ribavirin
- •Evidence of hepatic decompensation in cirrhotic subjects
- •Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
- •Part A only: subjects who have been on a HAART regimen within 12 weeks before study start
研究组 & 干预措施
Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: ribavirin (weight-based dose) (Drug)
Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: telaprevir or matching placebo (Drug)
Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: peginterferon alfa-2a (Biological)
Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: ribavirin (fixed dose) (Drug)
Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: ribavirin (weight-based dose) (Drug)
Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: telaprevir or matching placebo (Drug)
Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: peginterferon alfa-2a (Biological)
Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
干预措施: ribavirin (fixed dose) (Drug)
结局指标
主要结局
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
时间窗: 12 weeks after first dose of study drug
次要结局
- Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12(4 and 12 weeks after the first dose of study drug)
- Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment(12 weeks after last dose of study drug)
- Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)(through 12 weeks after first dose of study drug)
- Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)(through 12 weeks after first dose of study drug)
- Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure(through 12 weeks after first dose of study drug)