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 January 2017
Trial size 160 participants
Trial identifier NCT02738138, 2015-005577-20, M14-730


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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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
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

Primary Outcomes

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

Secondary Outcomes

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

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: 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 greater than or equal to 1000 IU/mL at Screening visit. 4. 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. 5. 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: 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.

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 October 2016.
Information provided to ClinicalTrials.gov by AbbVie.