A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-infection (EXPEDITION-2)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 160 人开始时间: 2016年5月16日最近更新: 2018年1月8日

研究概览

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•1. Male or female, at least 18 years of age at time of Screening.
•2. Screening laboratory result indicating HCV GT1-, 2-, 3-, 4-, 5-, or 6-infection.
•3. Subject has positive anti-HCV Ab and plasma HCV RNA viral load = 1000 IU/mL at Screening Visit.
•4. Subjects must be HCV treatment-naïve (i.e., subject has not received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed = 2 months prior to Screening.
•5. Subjects naïve to ART must have CD4+ count = 500 cells/mm3 (or CD4+ % = 29%) at Screening; or
•Subjects on a stable ART regimen must have the following:
•CD4+ count = 200 cells/mm3 (or CD4+ % = 14%) at Screening; and
•Plasma HIV-1 RNA below LLOQ at Screening and at least once during
•the 12 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 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
•2. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
•3. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
•4. Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
•5. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

发起方