NCT01471574已完成3 期
A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)
Bristol-Myers Squibb26 个研究点 分布在 3 个国家目标入组 549 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 549
- 试验地点
- 26
- 主要终点
- Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
研究概览
简要总结
The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV
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
- •Males and females, 18 to 70 years of age
- •Hepatitis C virus (HCV) genotype 1a or 1b
- •HCV-treatment naive
- •HCV RNA >10,000 IU/mL at screening
- •HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy [HAART], up to 50 patients not receiving HAART)
- •For patients receiving HAART, HIV RNA must be below <40 copies/mL at screening and must be <400 copies/ml for at least 6 months prior to screening
排除标准
- •Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
- •Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day
- •However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/ mL
- •Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
- •Laboratory values:
- •Neutrophil count <1500 cells/μL (<1200 cells/ μL for Blacks)
- •Platelet count <90,000 cells/μL
- •Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
- •Total bilirubin ≥34 μmol/L (or ≥2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir
- •Alanine aminotransferase ≥5*upper limit of normal
研究组 & 干预措施
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
Experimental
干预措施: Daclatasvir (Drug)
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
Experimental
干预措施: Ribavirin (Drug)
Daclatsvir + Ribavirin + PEG-Interferon alfa-2a
Experimental
干预措施: PEG-Interferon alfa 2a (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
时间窗: Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
次要结局
- Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)(Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24)
- Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)(Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24)
- Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL(End of treatment (up to Week 48))
- Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene(Follow-up Week 12)
- Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation(From Day 1 to 7 days post last dose of study treatment (up to Week 48))
研究者
研究点 (26)
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