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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 (TURQUOISE-I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01939197
First Posted: September 11, 2013
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
September 6, 2013
September 11, 2013
July 20, 2017
November 17, 2017
November 17, 2017
August 30, 2013
July 21, 2016   (Final data collection date for primary outcome measure)
Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]

SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution.

The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).

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 ]
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
  • Percentage of Participants in Part 1a Achieving SVR12 [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
  • Percentage of Participants in Part 1b Achieving SVR12 [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
  • Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12 [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
  • Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall [ Time Frame: 12 weeks after last dose of study drug ]
    SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.
  • Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period [ Time Frame: up to 12 or 24 weeks, based on treatment duration ]
    Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
  • Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period [ Time Frame: up to 12 weeks ]
    Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
  • Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period [ Time Frame: up to 12 or 24 weeks, based on treatment duration ]
    Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.
  • Percentage of Participants in Part 1a With Relapse12 [ Time Frame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug ]
    Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.
  • Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall [ Time Frame: up to 12 weeks after the last actual dose of study drug ]
    Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.
  • Percentage of Participants in Part 2 With Relapse12 [ Time Frame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug ]
    Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.
  • Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment [ Time Frame: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126) ]
    HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
  • Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment [ Time Frame: End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126) ]
    HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
  • Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment [ Time Frame: End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126) ]
    HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).
  • 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 ]
    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 ]
    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 ]
    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 ]
    The percentage of subjects with undetectable plasma human immunodeficiency virus, type 1 (HIV-1) ribonucleic acid.
Not Provided
Not Provided
 
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
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
    Other Names:
    • ombitasvir/paritaprevir/ritonavir
    • ombitasvir also known as ABT-267
    • paritaprevir also known as ABT-450
  • Drug: ABT-333
    tablet
    Other Name: Dasabuvir
  • Drug: ribavirin
    tablet
  • Experimental: ARM A
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM B
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM C
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM D
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM E
    ABT-450/r/ABT-267 and ABT-333 for 12 weeks for noncirrhotic (at screening) GT1b-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
  • Experimental: ARM F
    ABT-450/r/ABT-267 and ABT-333 for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
  • Experimental: ARM G
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-naive participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM H
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for cirrhotic (at screening) GT1b-infected sofosbuvir-experienced participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM I
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for noncirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM J
    ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for cirrhotic (at screening) GT1a-infected participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: ribavirin
  • Experimental: ARM K
    ABT-450/r/ABT-267 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ribavirin
  • Experimental: ARM L
    ABT-450/r/ABT-267 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily, darunavir once-daily
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ribavirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
October 25, 2016
July 21, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Canada,   France,   Germany,   Italy,   New Zealand,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom,   United States
 
NCT01939197
M14-004
2012-005143-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Rolando Viani, MD AbbVie
AbbVie
October 2017

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