A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of subjects with SVR12
研究概览
简要总结
The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA < 2000000 IU/mL
- •Never taken medication for HCV
- •No Liver Cirrhosis
- •No advanced fibrosis
- •Body mass index(BMI) 18-40 kg/m^2
- •Genotype 1-4
排除标准
- •Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype
- •Evidence of decompensated liver
- •Subjects Infected with HIV 2
- •Hepatitis B virus (HBV) coinfection
- •Liver Cirrhosis
- •Advanced fibrosis (F3-F4)
研究组 & 干预措施
Daclatasvir + Sofosbuvir
Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks
干预措施: Daclatasvir (Drug)
Daclatasvir + Sofosbuvir
Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Proportion of subjects with SVR12
时间窗: Post treatment follow-up week 12
SVR12 rate defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4
次要结局
- Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment(Approximately 2 years)
- Proportion of subjects receiving cART who experience HIV virologic failure(Approximately 2 years)
- Sustained virologic response (SVR12) rate(Approximately 2 years)
- Proportion of subjects receiving cART who maintain HIV virologic suppression(Approximately 2 years)
- Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF(Approximately 2 years)
- Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF(Approximately 2 years)