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)



Status:Recruiting
Conditions:Infectious Disease, Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:7/28/2016
Start Date:May 2016
End Date:May 2017
Contact:Barbara Cristofanelli
Email:barbara.cristofanelli@abbvie.com
Phone:+39 06-92892-3201

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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)

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.


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.
We found this trial at
14
sites
Dothan, Alabama 36303
Principal Investigator: Site Reference ID/Investigator# 149524, MD
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Dothan, AL
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Adelaide,
Principal Investigator: Site Reference ID/Investigator# 149220, MD
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Adelaide,
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Allentown, Pennsylvania
Principal Investigator: Site Reference ID/Investigator# 149228, DO
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Allentown, PA
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Balitmore, Maryland
Principal Investigator: Site Reference ID/Investigator# 149225, MD
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Balitmore, MD
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Chapel Hill, North Carolina
Principal Investigator: Site Reference ID/Investigator# 149200, MD
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Chapel Hill, NC
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Cincinnati, Ohio
Principal Investigator: Site Reference ID/Investigator# 149215, MD, PhD
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Cincinnati, OH
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Dallas, Texas 75390
Principal Investigator: Site Reference ID/Investigator# 149224, MD
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Dallas, TX
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Houston, Texas
Principal Investigator: Site Reference ID/Investigator# 150791, MD
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Houston, TX
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Los Angeles, California
Principal Investigator: Site Reference ID/Investigator# 149218, MD
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Los Angeles, CA
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Lynchburg, Virginia 24501
Principal Investigator: Site Reference ID/Investigator# 149199, MD
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Lynchburg, VA
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Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 149223, MD
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Newark, NJ
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San Diego, California
Principal Investigator: Site Reference ID/Investigator# 149227, MD
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San Diego, CA
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San Francisco, California
Principal Investigator: Site Reference ID/Investigator# 149525, MD
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San Francisco, CA
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Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 149226, MD
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Seattle, WA
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