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.
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01939197
First received: September 6, 2013
Last updated: April 8, 2014
Last verified: April 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 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: August 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: December 2014 (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
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
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 Child-Pugh B or C classification or clinical history of liver decompensation.
  • Chronic human immunodeficiency virus, type 2 (HIV-2) infection.
  Contacts and Locations
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: April 8, 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 C
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Liver Cirrhosis
Fibrosis
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Ritonavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014