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 July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01939197
First received: September 6, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus Infection
Human Immunodeficiency Virus Infection
Chronic Hepatitis C
Compensated Cirrhosis and Non-cirrhotics
Drug: ABT-450/r/ABT-267
Drug: ABT-333
Drug: Ribavirin (RBV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Ribavirin (RBV)
Tablet
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
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Ribavirin (RBV)
Tablet
Experimental: ARM C
ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for Darunavir once-daily subjects
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Ribavirin (RBV)
Tablet
Experimental: ARM D
ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for Darunavir twice-daily subjects
Drug: ABT-450/r/ABT-267
Tablet
Drug: ABT-333
Tablet
Drug: Ribavirin (RBV)
Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939197

Contacts
Contact: Melanie Gloria, BS 847-936-0714 melanie.gloria@abbvie.com
Contact: Karmin Robinson-Morgan, BS 847-935-5421 karmin.y.robinson@abbvie.com

  Show 28 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Roger Trinh, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01939197     History of Changes
Other Study ID Numbers: M14-004, 2012-005143-24
Study First Received: September 6, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
HCV Genotype 1
Hepatitis C Genotype 1
Compensated Cirrhosis
HCV / HIV coinfection
Interferon-Free
Hepatitis C
HIV-1
Cirrhotic

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Infection
Communicable Diseases
Virus Diseases
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Hepatitis, Chronic
Coinfection
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Parasitic Diseases
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014