A Two Part, Open-label Study to Evaluate the Safety and Effectiveness of ABT-450/r/ABT-267 or ABT-450/r/ABT-267 and ABT-333 Given With or Without a Drug Called Ribavirin in People With Both Hepatitis C Virus Genotype 1 or 4 Infection and Human Immunodeficiency Virus, Type 1 Infection (TURQUOISE-I)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01939197
First received: September 6, 2013
Last updated: April 28, 2015
Last verified: April 2015

September 6, 2013
April 28, 2015
August 2013
July 2016   (final data collection date for primary outcome measure)
Percentage of subjects in genotype 1 Analysis Group 1 in Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) compared to the historical SVR12 rate for sofosbuvir plus ribavirin as reported in the PHOTON-1 study [ 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 in genotype 1 Analysis Group 2 of Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) compared to the historical rate for sofosbuvir plus ribavirin [ 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 Part 1a subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in the 24-week treatment group compared to the 12-week treatment group using Fisher's exact test [ 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 of Part 1b subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in the darunavir once-daily arm compared to the darunavir twice-daily arm using Fisher's exact test [ 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 Part 1b subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) [ Time Frame: 12 weeks after the 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 Part 2 GT 1b cirrhotic subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in Arm F (without ribavirin) compared to Arm G (with ribavirin) using Fisher's exact test [ 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 genotype 4 subjects in Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) by arm and overall [ 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
  • Percentage of subjects with on treatment Hepatitis C Virus virologic failure during the Treatment Period for each arm in Part 1, set of all subjects in Part 1b, the genotype 1 Analysis Group 1 and 2 in Part 2, the GT4 Analysis Group by arm and overall [ 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 previously unquantifiable Hepatitis C Virus ribonucleic acid during treatment
  • The percentage of subjects with Hepatitis C Virus post-treatment relapse (analyses performed as described for secondary endpoint 7). [ 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
  • Percentage of subjects with plasma HIV-1 RNA suppression at end of treatment and 12 weeks post-treatment (analyses performed as described for secondary endpoint 7) and comparison of the darunavir once-daily and twice-daily arms in Part 1b [ 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 Two Part, Open-label Study to Evaluate the Safety and Effectiveness of ABT-450/r/ABT-267 or ABT-450/r/ABT-267 and ABT-333 Given With or Without a Drug Called Ribavirin in People With Both Hepatitis C Virus Genotype 1 or 4 Infection and Human Immunodeficiency Virus, Type 1 Infection
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 purpose of this study is to assess the safety and efficacy of ombitasvir/paritaprevir/ritonavir with and without dasabuvir coadministered with and without ribavirin for 12 and 24 weeks in adults with genotype 1 or 4 Chronic Hepatitis C Virus Infection with Human Immunodeficiency Virus, Type 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
    Other Name: Ombitasvir/Paritaprevir/Ritonavir
  • Drug: ABT-333
    Tablet
    Other Name: Dasabuvir
  • 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)
  • Experimental: ARM E
    ABT-450/r/ABT-267 and ABT-333 for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or 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 subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or 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 ribavirin (RBV) for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM H
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM I
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM J
    ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 24 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.
    Interventions:
    • Drug: ABT-450/r/ABT-267
    • Drug: ABT-333
    • Drug: Ribavirin (RBV)
  • Experimental: ARM K
    ABT-450/r/ABT-267 coadministered with ribavirin (RBV) for 12 weeks for subjects 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 (RBV)
  • Experimental: ARM L
    ABT-450/r/ABT-267 coadministered with ribavirin (RBV) for 24 weeks for subjects 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 (RBV)
Sulkowski MS, Eron JJ, Wyles D, Trinh R, Lalezari J, Wang C, Slim J, Bhatti L, Gathe J, Ruane PJ, Elion R, Bredeek F, Brennan R, Blick G, Khatri A, Gibbons K, Hu YB, Fredrick L, Schnell G, Pilot-Matias T, Tripathi R, Da Silva-Tillmann B, McGovern B, Campbell AL, Podsadecki T. Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial. JAMA. 2015 Mar 24-31;313(12):1223-31. doi: 10.1001/jama.2015.1328.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
September 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic HCV infection defined as: Positive anti-HCV Ab or 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 human immunodeficiency virus, type 1 (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.
Both
18 Years and older
No
Contact: Karmin Robinson-Morgan, BS 847-935-5421 karmin.y.robinson@abbvie.com
Contact: Krystal Gibbons, BA 847-935-9398 krystal.gibbons@abbvie.com
United States,   Puerto Rico
 
NCT01939197
M14-004, 2012-005143-24
Yes
AbbVie
AbbVie
Not Provided
Study Director: Roger Trinh, MD AbbVie
AbbVie
April 2015

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