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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
Results First Submitted: July 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis C Virus Infection
Human Immunodeficiency Virus Infection
Chronic Hepatitis C
Compensated Cirrhosis and Non-cirrhotics
Interventions: Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Part 2 was not designed to test different treatments on the same subject population. Rather, the arms in Part 2 represent subpopulations with different baseline characteristics (hepatitis C virus [HCV] genotype [GT], cirrhotic status, prior HCV therapy experience). Arms F and G were randomized to regimens without and with ribavirin, respectively.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Part 2, participants in Arms E, F, H, I, J all had GT1 infection and received 1 consistent treatment regimen based on label recommendations; they were therefore combined and named the "GT1 Analysis Group."

Reporting Groups
  Description
Part 1a: 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
Part 1a: 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
Part 1b: Arm C ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
Part 1b: Arm D ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
Part 2: GT1 Analysis Group Participants with HCV genotype (GT)1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Part 2: Arm G ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
GT4 Analysis Group

Participants with HCV GT4 at screening in Arms K and L (no participants enrolled in Arm L).

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


Participant Flow:   Overall Study
    Part 1a: Arm A   Part 1a: Arm B   Part 1b: Arm C   Part 1b: Arm D   Part 2: GT1 Analysis Group   Part 2: Arm G   GT4 Analysis Group
STARTED   31   32   10   12   200   5   28 
COMPLETED   30   31   10   11   196   4   26 
NOT COMPLETED   1   1   0   1   4   1   2 
Withdrawal by Subject                1                0                0                0                1                0                0 
Lost to Follow-up                0                1                0                1                3                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Part 1a: Arm A ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving atazanavir once-daily or raltegravir twice-daily
Part 1a: 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
Part 1b: Arm C ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir once-daily
Part 1b: Arm D ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving darunavir twice-daily
Part 2: GT1 Analysis Group Participants with HCV GT1a or GT1b at screening in Arms E, F, H, I, J (no participants enrolled in Arm H) Arm E: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm F: ABT-450/r/ABT-267 and ABT-333 for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm I: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily Arm J: ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 24 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Part 2: Arm G ABT-450/r/ABT-267 and ABT-333 coadministered with RBV for 12 weeks for participants receiving any of the following: atazanavir once-daily, raltegravir twice-daily
Part 2: GT4 Analysis Group 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 Arm L: no participants enrolled
Total Total of all reporting groups

Baseline Measures
   Part 1a: Arm A   Part 1a: Arm B   Part 1b: Arm C   Part 1b: Arm D   Part 2: GT1 Analysis Group   Part 2: Arm G   Part 2: GT4 Analysis Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   32   10   12   200   5   28   318 
Age, Customized 
[Units: Participants]
Count of Participants
               
Age Group                 
< 55 years      23  74.2%      20  62.5%      5  50.0%      8  66.7%      145  72.5%      2  40.0%      24  85.7%      227  71.4% 
≥ 55 years      8  25.8%      12  37.5%      5  50.0%      4  33.3%      55  27.5%      3  60.0%      4  14.3%      91  28.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      2   6.5%      3   9.4%      2  20.0%      3  25.0%      44  22.0%      1  20.0%      2   7.1%      57  17.9% 
Male      29  93.5%      29  90.6%      8  80.0%      9  75.0%      156  78.0%      4  80.0%      26  92.9%      261  82.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Percentage of Participants in Part 1a Achieving SVR12   [ Time Frame: 12 weeks after last dose of study drug ]

3.  Secondary:   Percentage of Participants in Part 1b Achieving SVR12   [ Time Frame: 12 weeks after last dose of study drug ]

4.  Secondary:   Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12   [ Time Frame: 12 weeks after last dose of study drug ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period   [ Time Frame: up to 12 weeks ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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) ]

13.  Secondary:   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) ]

14.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie
phone: 800-633-9110


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01939197     History of Changes
Other Study ID Numbers: M14-004
2012-005143-24 ( EudraCT Number )
First Submitted: September 6, 2013
First Posted: September 11, 2013
Results First Submitted: July 20, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017