A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With… (NCT02738138) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
153 participantsStarted 2016-05-17
Plain-language summary
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Male or female, at least 18 years of age at time of Screening.
✓. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
✓. Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
✓. Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon \[pegIFN\] with or without ribavirin \[RBV\], or sofosbuvir \[SOF\] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.
✓. Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm\^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have
Exclusion criteria
✕. 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.
✕. Positive test result at Screening for hepatitis B surface antigen (HBsAg).
✕. Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
✕. 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).
What they're measuring
1
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)