EUCTR2011-003067-30-GB进行中（未招募）1 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) + Pharmacogenetics Blood Sample Amendment 01, version 1.0 dated 06-Oct-11
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 549
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Males and females, 18 to 70 years of age;
- •HCV Genotype 1a or 1b;
- •HCV-Treatment naive;
- •HCV RNA > 10,000 IU/mL at screening;
- •HIV-1 infection;(approximately 250 subjects receiving HAART, up to 50 subjects not receiving HAART);
- •For subjects 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;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 475
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Subjects (receiving HAART) who had first initiated anti-retroviral therapy within the last 6 months of Day 1;
- •Subjects (receiving HAART) who have changed their anti-retroviral
- •regimen within the last 3 months prior to Day 1 (other than prohibited HAART regimens (see section 3.4.1), which may be substituted at least one month prior to Day 1);
- •Use of prohibited HAART;regimens (see section 3.4.1) within one month of Day 1 and throughout the treatment period of the trial;
- •Laboratory values:
- •neutrophil count < 1500 cells/µL (<1200 cells/ µL for blacks), platelet count < 90,000 cells/µL, hemoglobin < 11 g/dL for females, hemoglobin < 12 g/dL for males;
- •Total bilirubin = 34 µmol/L (or = 2 mg/dL) unless subject has a documented history of Gilbert’s disease or antiretroviral regimen contains atazanavir.
研究者
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