A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (TURQUOISE-I)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01939197
First received: September 6, 2013
Last updated: October 10, 2014
Last verified: October 2014

September 6, 2013
October 10, 2014
August 2013
September 2015   (final data collection date for primary outcome measure)
Percentage of subjects achieving sustained virologic response 12 weeks post-treatment within each treatment group based on treatment duration [ Time Frame: 12 weeks after the last actual dose of study drug ] [ Designated as safety issue: No ]
Hepatitis C Virus ribonucleic acid less than the lower limit of quantification
Percentage of subjects in each treatment group with sustained virologic response 12 weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ] [ Designated as safety issue: No ]
Hepatitis C virus ribonucleic acid less than the lower limit of quantification
Complete list of historical versions of study NCT01939197 on ClinicalTrials.gov Archive Site
  • The percentage of subjects achieving sustained virologic response 12 weeks post-treatment compared between treatment groups based on treatment durations [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]
    Hepatitis C Virus ribonucleic acid less than the lower limit of quantification
  • The percentage of subjects with on-treatment Hepatitis C Virus virologic failure during the Treatment Period in each treatment group based on treatment duration [ Time Frame: up to 12 or 24 weeks based on treatment duration ] [ Designated as safety issue: No ]
    Percentage of subjects with confirmed quantifiable Hepatitis C Virus ribonucleic acid among subjects with previous unquantifiable Hepatitis C Virus ribonucleic acid during treatment
  • The percentage of subjects with Hepatitis C Virus post-treatment relapse in each treatment group based on treatment duration [ Time Frame: within 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    The percentage of subjects with confirmed quantifiable Hepatitis C Virus ribonucleic acid among subjects with unquantifiable Hepatitis C Virus ribonucleic acid at the end of treatment
  • The percentage of subjects with plasma human immunodeficiency virus, type 1 (HIV-1) ribonucleic acid suppression at the end of treatment and 12 weeks post-treatment for the treatment groups based on treatment duration [ Time Frame: up to 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    The percentage of subjects with unquantifiable plasma human immunodeficiency virus, type 1 (HIV-1) ribonucleic acid.
  • The percentage of subjects with sustained virologic response 12 weeks post-treatment following treatment with different durations [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification
  • The percentage of subjects in each arm with on-treatment virologic failure during the Treatment Period [ Time Frame: up to 12 or 24 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with confirmed quantifiable Hepatitis C virus ribonucleic acid among subjects with previous unquantifiable Hepatitis C virus ribonucleic acid during treatment
  • The percentage of subjects in each arm with post-treatment relapse [ Time Frame: within 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    The percentage of subjects with confirmed quantifiable Hepatitis C virus ribonucleic acid among subjects with unquantifiable Hepatitis C virus ribonucleic acid at the end of treatment
  • The percentage of subjects in each arm with maintenance of plasma human immunodeficiency virus, type 1 (HIV-1) ribonucleic acid suppression. [ Time Frame: up to 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]
    The percentage of subjects with undetectable plasma human immunodeficiency virus, type 1 (HIV-1) ribonucleic acid.
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection
A Randomized Open-label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (TURQUOISE-I)

The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 and ABT-333 coadministered with RBV in HCV genotype 1 adults with HIV-1 coinfection.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C Virus Infection
  • Human Immunodeficiency Virus Infection
  • Chronic Hepatitis C
  • Compensated Cirrhosis and Non-cirrhotics
  • Drug: ABT-450/r/ABT-267
    Tablet
  • Drug: ABT-333
    Tablet
  • Drug: Ribavirin (RBV)
    Tablet
  • Experimental: ARM A
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for Atazanavir once-daily or Raltegravir twice-daily subjects
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM B
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 24 weeks for Atazanavir once-daily or Raltegravir twice-daily subjects
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM C
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for Darunavir once-daily subjects
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM D
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for Darunavir twice-daily subjects
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2016
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced.
  • Screening laboratory result indicating HCV genotype 1-infection.
  • Plasma HIV-1 RNA <40 copies/mL during Screening.
  • On a stable qualifying human immunodeficiency virus, type 1 (HIV-1) antiretroviral therapy regimen.

Exclusion Criteria:

  • Positive test result at screening for Hepatitis B surface antigen.
  • Prior therapy with direct acting antivirals for the treatment of HCV.
  • Any current or past clinical evidence of liver decompensation.
  • Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
Both
18 Years to 70 Years
No
Contact: Melanie Gloria, BS 847-936-0714 melanie.gloria@abbvie.com
Contact: Karmin Robinson-Morgan, BS 847-935-5421 karmin.y.robinson@abbvie.com
United States,   Puerto Rico
 
NCT01939197
M14-004, 2012-005143-24
Yes
AbbVie
AbbVie
Not Provided
Study Director: Roger Trinh, MD AbbVie
AbbVie
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP