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) (EXPEDITION-2)
Information provided by (Responsible Party)
First received: April 11, 2016
Last updated: April 9, 2018
Last Verified: April 2018
History of Changes
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.
Hepatitis C Virus Infection
Human Immunodeficiency Virus Infection
Chronic Hepatitis C
Compensated Cirrhosis and Non-cirrhotics
Drug : ABT-493 coformulated with ABT-530
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
Further study details as provided by AbbVie:
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
[ Time Frame: 12 weeks after last dose of study drug ]
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
- Percentage of Participants With On-treatment Virologic Failure
[ Time Frame: Up to 12 weeks ]
On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
- Percentage of Participants With Post-treatment Relapse
[ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
|Study Start Date:||May 17, 2016|
|Study Completion Date:||June 7, 2017|
|Primary Completion Date:||March 15, 2017 (Final data collection date for primary outcome measure)|
ABT-493/ABT-530 for 8 weeks
HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks
ABT-493 coformulated with ABT-530
ABT-493/ABT-530 for 12 weeks
HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks
ABT-493 coformulated with ABT-530
|Ages Eligible for Study:||18 Years to 99 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02738138
Sponsors and CollaboratorsAbbVie
|Study Director:||AbbVie Inc||AbbVie|
Additional Information:Related Info
|ClinicalTrials.gov Identifier:||NCT02738138 History of Changes|
|Other Study ID Numbers:||M14-730|
|Study First Received:||April 11, 2016|
|Last Updated:||April 9, 2018|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by AbbVie:HCV Genotype 3
HCV Genotype 1
HCV Genotype 6
Human Immunodeficiency Virus (HIV) Infection
HCV Genotype 5
HCV Treatment Naive
HCV Genotype 4
HCV Treatment Experienced
HCV Genotype 2
Hepatitis C Virus (HCV) Infection
Additional relevant MeSH terms:
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.