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 July 2015 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01939197
First received: September 6, 2013
Last updated: July 20, 2015
Last verified: July 2015
  Purpose

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.


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 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 320
Study Start Date: August 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (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
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: ABT-333
Tablet
Other Name: Dasabuvir
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
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: ABT-333
Tablet
Other Name: Dasabuvir
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
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: ABT-333
Tablet
Other Name: Dasabuvir
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
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: ABT-333
Tablet
Other Name: Dasabuvir
Drug: Ribavirin (RBV)
Tablet
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.
Drug: ABT-450/r/ABT-267
Tablet
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: ABT-333
Tablet
Other Name: Dasabuvir
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.
Drug: ABT-450/r/ABT-267
Tablet
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: ABT-333
Tablet
Other Name: Dasabuvir
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.
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 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.
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 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.
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 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.
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 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.
Drug: ABT-450/r/ABT-267
Tablet
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: Ribavirin (RBV)
Tablet
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.
Drug: ABT-450/r/ABT-267
Tablet
Other Name: Ombitasvir/Paritaprevir/Ritonavir
Drug: Ribavirin (RBV)
Tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HCV infection at Screening defined as: Positive anti-HCV 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 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.
  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: Karmin Robinson-Morgan, BS 847-935-5421 karmin.y.robinson@abbvie.com
Contact: Nela Hayes, BA 847-935-1654 nela.hayes@abbvie.com

  Show 53 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Roger Trinh, MD AbbVie
  More Information

Additional Information:
No publications provided by AbbVie

Additional 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
Study First Received: September 6, 2013
Last Updated: July 20, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Research Ethics Committee
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
New Zealand: Medsafe
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Ethics Committee
Spain: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
Australia: Human Research Ethics Committee
Mexico: Ethics Committee
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by AbbVie:
HCV Genotype 1
Hepatitis C Genotype 1
Compensated Cirrhosis
HCV / HIV coinfection
Interferon-Free
Hepatitis C
HIV-1
Cirrhotic
Hepatitis C Genotype 4
HCV Genotype 4

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

ClinicalTrials.gov processed this record on August 26, 2015