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Completed

NCT Number: NCT01939197

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

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.

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Key information

Conditions

Hepatitis C Virus Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Chronic Disease Chronic Hepatitis C Communicable Diseases Compensated Cirrhosis and Non-cirrhotics Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Human Immunodeficiency Virus Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-450/r/ABT-267

Drug

tablet

Other names: ombitasvir/paritaprevir/ritonavir, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450

ABT-333

Drug

tablet

Other names: Dasabuvir

Ribavirin

Drug

tablet

Primary outcomes

  1. 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%).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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)

Acronym: TURQUOISE-I

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2013
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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