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).Revised Protocol Number 02 Incorporating Amendment 05 + Pharmacogenetics Blood Sample Amendment 01, version 1.0 dated 06-Oct-11

Bristol-Myers Squibb International Corporation0 个研究点目标入组 500 人开始时间: 2011年12月14日最近更新: 2015年8月17日

适应症

试验速览

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•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

•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 due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1 however if changes are required to a subject's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. Subject should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, < 40 copies/ mL. Subjects (receiving HAART) who have changed their anti-retroviral regimen to initiate any HCV treatment within 6 weeks 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. For those subjects requiring HAART therapy modifications for study entry, a repeat HIV RNA level is required prior to Day 1 after the modification is
•applied, to confirm study eligibility;
•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 subject has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir.

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