Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Sustained virological response.
研究概览
简要总结
Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.
详细描述
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir
Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years of age
- •Patients with early chronic hepatitis C (Genotype 1 or 4) which is defined as chronic hepatitis C with known episode of AHC within the last 4 years including those who failed to PEG/RBV or those who never received therapy for AHC. AHC infection is diagnosed on the basis of documented HCV-RNA positivity (> 10.000 IU/mL) and anti-HCV seroconversion.
- •No history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
- •Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result <8 kPa
- •Be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
- •Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to study entry using a dual NRTI backbone of tenofovir or abacavir
排除标准
- •< 18 years of age
- •Patients with chronic hepatitis C genotypes other than 1 or
- •History of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
- •Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result > 8kPa
- •Not be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
- •Due to known or suspected drug-drug interactions, for the purpose of this study, the use of Non Nucleoside Reverse Transcriptase Inhibitors, Inhibitors or Protease Inhibitors against HIV will be not allow.
研究组 & 干预措施
Genotype 1b
Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
干预措施: Grazoprevir 100 mg/d 8 weeks (Drug)
Genotype 1b
Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
干预措施: Elbasvir 50 mg/d 8 weeks (Drug)
Genotype 1a and 4
Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
干预措施: Grazoprevir 100 mg/d 12 weeks (Drug)
Genotype 1a and 4
Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
干预措施: Elbasvir 50 mg/d 12 weeks (Drug)
结局指标
主要结局
Sustained virological response.
时间窗: 24 weeks
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
次要结局
- Reinfection rate(1 year)
- Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.(2 years)
- Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.(2 years)
研究者
Anna Cruceta
Project manager
Fundacion Clinic per a la Recerca Biomédica