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)
This trial is active, not recruiting.
|Conditions||hepatitis c virus infection, human immunodeficiency virus infection, chronic hepatitis c, compensated cirrhosis and non-cirrhotics|
|Start date||May 2016|
|End date||March 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|
|Dothan, AL||Site Reference ID/Investigator# 149524||no longer recruiting|
|Los Angeles, CA||Site Reference ID/Investigator# 149218||no longer recruiting|
|San Diego, CA||Site Reference ID/Investigator# 149227||no longer recruiting|
|San Francisco, CA||Site Reference ID/Investigator# 149525||no longer recruiting|
|Balitmore, MD||Site Reference ID/Investigator# 149225||no longer recruiting|
|Newark, NJ||Site Reference ID/Investigator# 149223||no longer recruiting|
|Chapel Hill, NC||Site Reference ID/Investigator# 149200||no longer recruiting|
|Cincinnati, OH||Site Reference ID/Investigator# 149215||no longer recruiting|
|Allentown, PA||Site Reference ID/Investigator# 149228||no longer recruiting|
|Dallas, TX||Site Reference ID/Investigator# 149224||no longer recruiting|
|Houston, TX||Site Reference ID/Investigator# 150791||no longer recruiting|
|Lynchburg, VA||Site Reference ID/Investigator# 149199||no longer recruiting|
|Seattle, WA||Site Reference ID/Investigator# 149226||no longer recruiting|
|Adelaide, Australia||Site Reference ID/Investigator# 149220||no longer recruiting|
|Darlinghurst, Australia||Site Reference ID/Investigator# 149211||no longer recruiting|
|Parkville, Australia||Site Reference ID/Investigator# 149219||no longer recruiting|
|Gomel, Belarus||Site Reference ID/Investigator# 149303||no longer recruiting|
|Lyon, France||Site Reference ID/Investigator# 149202||no longer recruiting|
|Marseilles, France||Site Reference ID/Investigator# 149213||no longer recruiting|
|Paris, France||Site Reference ID/Investigator# 151272||no longer recruiting|
|Paris, France||Site Reference ID/Investigator# 149201||no longer recruiting|
|Paris, France||Site Reference ID/Investigator# 149231||no longer recruiting|
|Bonn, Germany||Site Reference ID/Investigator# 149217||no longer recruiting|
|Frankfurt am Main, Germany||Site Reference ID/Investigator# 149302||no longer recruiting|
|Hamburg, Germany||Site Reference ID/Investigator# 149230||no longer recruiting|
|Bialystok, Poland||Site Reference ID/Investigator# 149203||no longer recruiting|
|Chorzow, Poland||Site Reference ID/Investigator# 149208||no longer recruiting|
|Warsaw, Poland||Site Reference ID/Investigator# 149207||no longer recruiting|
|Bayamon, Puerto Rico||Site Reference ID/Investigator# 149523||no longer recruiting|
|Ponce, Puerto Rico||Site Reference ID/Investigator# 149221||no longer recruiting|
|San Juan, Puerto Rico||Site Reference ID/Investigator# 149629||no longer recruiting|
|Krasnoyarsk, Russian Federation||Site Reference ID/Investigator# 149204||no longer recruiting|
|Moscow, Russian Federation||Site Reference ID/Investigator# 149222||no longer recruiting|
|Saint-Petersburg, Russian Federation||Site Reference ID/Investigator# 149216||no longer recruiting|
|Edinburgh, United Kingdom||Site Reference ID/Investigator# 149209||no longer recruiting|
|London, United Kingdom||Site Reference ID/Investigator# 149210||no longer recruiting|
|London, United Kingdom||Site Reference ID/Investigator# 149196||no longer recruiting|
|Intervention model||parallel assignment|
Percentage of subjects with sustained virologic response 12 weeks after treatment
time frame: 12 weeks after last dose of study drug
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
All participants from 18 years up to 99 years old.
- 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.
- 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.
|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)|
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