Overview

This trial is active, not recruiting.

Conditions hepatitis c virus infection, human immunodeficiency virus infection, chronic hepatitis c, compensated cirrhosis and non-cirrhotics
Treatment abt-493/abt-530
Phase phase 3
Sponsor AbbVie
Start date May 2016
End date March 2017
Trial size 160 participants
Trial identifier NCT02738138, 2015-005577-20, M14-730

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
abt-493/abt-530 Glecaprevir/Pibrentasvir
Tablet
(Experimental)
HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
abt-493/abt-530 Glecaprevir/Pibrentasvir
Tablet

Primary Outcomes

Measure
Percentage of subjects with sustained virologic response 12 weeks after treatment
time frame: 12 weeks after last dose of study drug

Secondary Outcomes

Measure
Percentage of subjects with on-treatment HCV (Hepatitis C Virus) virologic failure in subject
time frame: Up to 12 weeks
The percentage of subjects with post-treatment HCV relapse
time frame: Up to 12 weeks after last dose of study drug

Eligibility Criteria

All participants from 18 years up to 99 years old.

Inclusion Criteria

  • Male or female, at least 18 years of age at time of Screening.
  • Screening laboratory result indicating HCV GT1-, 2-, 3-, 4-, 5-, or 6-infection.
  • Subject has positive anti-HCV Ab and plasma HCV 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 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 greater than or equal to 2 months prior to Screening.
  • Subjects naïve to ART must have CD4+ count great 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
    • CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and
    • Plasma HIV-1 RNA below LLOQ at Screening and at least once during the 12 months prior to Screening.

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).
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530.

Additional Information

Official title A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by AbbVie.