Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects With Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 163
- 主要终点
- Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).
详细描述
This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic (detectable HCV Ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL
- •Confirmed diagnosis of HIV-1 infection greater than 6 months before the screening visit
- •CD4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit
- •HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit
- •No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit
- •Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks
排除标准
- •Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period
- •Infection or co-infection with HCV other than genotype 1
- •Contraindication to the administration of Peg-IFN-alfa or RBV
- •Hepatitis B virus (HBV) co-infection
- •Acute or active condition of HIV-associated opportunistic infection within 6 months of screening
研究组 & 干预措施
Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)
All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.
干预措施: Telaprevir (Drug)
Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)
All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.
干预措施: Ribavirin (Drug)
Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)
All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.
干预措施: Pegylated-Interferon-alfa-2a (Drug)
结局指标
主要结局
Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
时间窗: Up to 48 weeks
Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
次要结局
- Change from baseline in log HCV RNA values(Baseline and week 48)
- Proportion of patients achieving undetectable HCV RNA levels at Week 4(Up to 48 weeks)
- Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)(Up to 48 weeks)
- Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels(Up to 48 weeks)
- Proportiond of patients achieving undetectable HCV RNA levels(Up to 48 weeks)
- Proportion of patients achieving undetectable HCV RNA levels at Week 12(Up to 48 weeks)
- Proportion of patients achieving undetectable HCV RNA at the actual end of treatment(Up to 48 weeks)
- Proportion of patients achieving less than 25 IU/mL(Up to 48 weeks)
- Proportion of patients with on-treatment virologic failure(Up to 48 weeks)
- Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels(Up to 48 weeks)