A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection

Study Identifier
M14-004
CT.gov Identifier
NCT01939197
EudraCT Identifier
2012-005143-24
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
  • Human Immunodeficiency Virus (HIV)
  • Cirrhosis
    • Study Drug
  • ABT-450/r/ABT-267
  • ABT-333
  • ribavirin
    • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Chronic HCV infection at screening defined as: positive anti-HCV antibodies (Ab) at screening and HCV RNA \> 1,000 IU/mL at screening. * Plasma HIV-1 RNA \< 40 copies/mL during screening using Abbott RealTime HIV-1 assay. * On a stable qualifying HIV-1 antiretroviral therapy regimen.
    Exclusion Criteria:
    * Positive test result at screening for hepatitis B surface antigen. * Evidence of HCV genotype other than genotype 1 or genotype 4 during screening. * Receipt of any other investigational or commercially available anti-HCV agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin. * Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin. * Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

    Protocol Summary

    The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of subjects achieving HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment.

    Study Locations

    No locations found.