Phase
Condition
Aids And Aids Related Infections
Hiv/aids
Hepatitis
Treatment
N/AClinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 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.
- 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:
- 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.
- 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-HCVagents 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 unsuitablecandidate to receive ABT-493/ABT-530.
Study Design
Connect with a study center
Royal Adelaide Hospital /ID# 149220
Adelaide, 5000
AustraliaSite Not Available
St. Vincent's Hospital /ID# 149211
Darlinghurst, 2010
AustraliaSite Not Available
Royal Melbourne Hospital /ID# 149219
Parkville, 3050
AustraliaSite Not Available
Site Reference ID/Investigator# 149397
Brest, 224027
BelarusSite Not Available
Gomel Regional Clinical Hospital of Infectious Diseases /ID# 149303
Gomel, 246044
BelarusSite Not Available
Hopital de la Croix Rousse /ID# 149202
Lyon, 69004
FranceSite Not Available
Hopital Sainte Marguerite /ID# 149213
Marseilles, 13009
FranceSite Not Available
Hopital Tenon /ID# 149201
Paris, 75020
FranceSite Not Available
Universitaetsklinikum Bonn (AoR) /ID# 149217
Bonn, 53127
GermanySite Not Available
Infektiologikum /ID# 149302
Frankfurt am Main, 60596
GermanySite Not Available
ifi-Studien und Projekte Gmbh /ID# 149230
Hamburg, 20099
GermanySite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 149203
Bialystok, 15-540
PolandSite Not Available
Szpital Specjalistyczny w Chorzowie /ID# 149208
Chorzow, 41-500
PolandSite Not Available
Wojewodzki Szpital Zakazny /ID# 149207
Warsaw, 01-201
PolandSite Not Available
Innovative Care P.S.C. /ID# 149523
Bayamon, 00959
Puerto RicoSite Not Available
Instituto de Investigacion Cientifica del Sur /ID# 149221
Ponce, 00730
Puerto RicoSite Not Available
HOPE Clinical Research /ID# 149629
San Juan, 00909
Puerto RicoSite Not Available
Regional state independent healthcare Institution /ID# 149204
Krasnoyarsk, 660049
Russian FederationSite Not Available
Infectious clinical hospital #2 /ID# 149222
Moscow, 105257
Russian FederationSite Not Available
SPb SBIH "Center for Prevention and Control of AIDS and Infe /ID# 149216
Saint-Petersburg, 190103
Russian FederationSite Not Available
Western General Hospital /ID# 149209
Edinburgh, EH4 2XU
United KingdomSite Not Available
The Royal Free Hospital /ID# 149196
London, NW3 2QG
United KingdomSite Not Available
Digestive Health Specialists of the Southeast /ID# 149524
Dothan, Alabama 36305
United StatesSite Not Available
Ruane Clinical Research Group Inc. /ID# 149218
Los Angeles, California 90036
United StatesSite Not Available
UCSD Antiviral Research Center (AVRC) /ID# 149227
San Diego, California 92103
United StatesSite Not Available
University of California, San Francisco /ID# 149525
San Francisco, California 94110
United StatesSite Not Available
Site Reference ID/Investigator# 149225
Balitmore, Maryland 21287
United StatesSite Not Available
Johns Hopkins University School of Medicine /ID# 149225
Baltimore, Maryland 21287
United StatesSite Not Available
Saint Michaels Medical Center /ID# 149223
Newark, New Jersey 07102
United StatesSite Not Available
University of North Carolina at Chapel Hill /ID# 149200
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University of Cincinnati Physicians Company LLC /ID# 149215
Cincinnati, Ohio 45267-0595
United StatesSite Not Available
Lehigh Valley Health Network/Lehigh Valley Hospital /ID# 149228
Allentown, Pennsylvania 18102
United StatesSite Not Available
North Texas Infectious Diseases Consultants, PA /ID# 149224
Dallas, Texas 75246
United StatesSite Not Available
Therapeutic Concepts P.A. /ID# 150791
Houston, Texas 77004
United StatesSite Not Available
Infectious Diseases Associates of Central Virginia /ID# 149199
Lynchburg, Virginia 24501
United StatesSite Not Available
Virginia Mason Hospital & Seattle Medical Center /ID# 149226
Seattle, Washington 98101
United StatesSite Not Available

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