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)

Last updated: July 9, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Aids And Aids Related Infections

Hiv/aids

Hepatitis

Treatment

N/A

Clinical Study ID

NCT02738138
M14-730
2015-005577-20
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, at least 18 years of age at time of Screening.
  2. Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
  3. 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.
  4. Subjects must be HCV treatment-naïve (i.e., subject has never received a single doseof any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or withoutribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjectsmust be HCV treatment-naïve. Previous HCV treatment must have been completed greaterthan or equal to 2 months prior to Screening.
  5. Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than orequal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; orSubjects on a stable ART regimen must have
  • CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than orequal to 14%) at Screening; and
  • Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and atleast once during the 12 months prior to Screening.

Exclusion

Exclusion Criteria:

  1. Recent (within 6 months prior to study drug administration) history of drug or alcoholabuse that could preclude adherence to the protocol in the opinion of theinvestigator.
  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-HCVagents 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 unsuitablecandidate to receive ABT-493/ABT-530.

Study Design

Total Participants: 153
Study Start date:
May 17, 2016
Estimated Completion Date:
June 07, 2017

Connect with a study center

  • Royal Adelaide Hospital /ID# 149220

    Adelaide, 5000
    Australia

    Site Not Available

  • St. Vincent's Hospital /ID# 149211

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Royal Melbourne Hospital /ID# 149219

    Parkville, 3050
    Australia

    Site Not Available

  • Site Reference ID/Investigator# 149397

    Brest, 224027
    Belarus

    Site Not Available

  • Gomel Regional Clinical Hospital of Infectious Diseases /ID# 149303

    Gomel, 246044
    Belarus

    Site Not Available

  • Hopital de la Croix Rousse /ID# 149202

    Lyon, 69004
    France

    Site Not Available

  • Hopital Sainte Marguerite /ID# 149213

    Marseilles, 13009
    France

    Site Not Available

  • Hopital Tenon /ID# 149201

    Paris, 75020
    France

    Site Not Available

  • Universitaetsklinikum Bonn (AoR) /ID# 149217

    Bonn, 53127
    Germany

    Site Not Available

  • Infektiologikum /ID# 149302

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • ifi-Studien und Projekte Gmbh /ID# 149230

    Hamburg, 20099
    Germany

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 149203

    Bialystok, 15-540
    Poland

    Site Not Available

  • Szpital Specjalistyczny w Chorzowie /ID# 149208

    Chorzow, 41-500
    Poland

    Site Not Available

  • Wojewodzki Szpital Zakazny /ID# 149207

    Warsaw, 01-201
    Poland

    Site Not Available

  • Innovative Care P.S.C. /ID# 149523

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • Instituto de Investigacion Cientifica del Sur /ID# 149221

    Ponce, 00730
    Puerto Rico

    Site Not Available

  • HOPE Clinical Research /ID# 149629

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Regional state independent healthcare Institution /ID# 149204

    Krasnoyarsk, 660049
    Russian Federation

    Site Not Available

  • Infectious clinical hospital #2 /ID# 149222

    Moscow, 105257
    Russian Federation

    Site Not Available

  • SPb SBIH "Center for Prevention and Control of AIDS and Infe /ID# 149216

    Saint-Petersburg, 190103
    Russian Federation

    Site Not Available

  • Western General Hospital /ID# 149209

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • The Royal Free Hospital /ID# 149196

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Digestive Health Specialists of the Southeast /ID# 149524

    Dothan, Alabama 36305
    United States

    Site Not Available

  • Ruane Clinical Research Group Inc. /ID# 149218

    Los Angeles, California 90036
    United States

    Site Not Available

  • UCSD Antiviral Research Center (AVRC) /ID# 149227

    San Diego, California 92103
    United States

    Site Not Available

  • University of California, San Francisco /ID# 149525

    San Francisco, California 94110
    United States

    Site Not Available

  • Site Reference ID/Investigator# 149225

    Balitmore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine /ID# 149225

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Saint Michaels Medical Center /ID# 149223

    Newark, New Jersey 07102
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill /ID# 149200

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of Cincinnati Physicians Company LLC /ID# 149215

    Cincinnati, Ohio 45267-0595
    United States

    Site Not Available

  • Lehigh Valley Health Network/Lehigh Valley Hospital /ID# 149228

    Allentown, Pennsylvania 18102
    United States

    Site Not Available

  • North Texas Infectious Diseases Consultants, PA /ID# 149224

    Dallas, Texas 75246
    United States

    Site Not Available

  • Therapeutic Concepts P.A. /ID# 150791

    Houston, Texas 77004
    United States

    Site Not Available

  • Infectious Diseases Associates of Central Virginia /ID# 149199

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Virginia Mason Hospital & Seattle Medical Center /ID# 149226

    Seattle, Washington 98101
    United States

    Site Not Available

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