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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01939197
First received: September 6, 2013
Last updated: November 1, 2016
Last verified: November 2016
  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 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


Enrollment: 319
Study Start Date: August 2013
Study Completion Date: October 2016
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 to 99 Years   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 95592
Birmingham, Alabama, United States, 35294
United States, Arizona
Site Reference ID/Investigator# 95581
Tucson, Arizona, United States, 85724-5136
United States, California
Site Reference ID/Investigator# 95580
Beverly Hills, California, United States, 90211
Site Reference ID/Investigator# 95591
Los Angeles, California, United States, 90036
Site Reference ID/Investigator# 98364
Riverside, California, United States, 92506
Site Reference ID/Investigator# 95599
San Diego, California, United States, 92103-8208
Site Reference ID/Investigator# 95583
San Francisco, California, United States, 94109
Site Reference ID/Investigator# 113695
San Francisco, California, United States, 94110
Site Reference ID/Investigator# 102936
San Francisco, California, United States, 94115
United States, Colorado
Site Reference ID/Investigator# 95584
Aurora, Colorado, United States, 80045
United States, Connecticut
Site Reference ID/Investigator# 102975
Norwalk, Connecticut, United States, 06850
United States, District of Columbia
Site Reference ID/Investigator# 95585
Washington, District of Columbia, United States, 20009
United States, Florida
Site Reference ID/Investigator# 136914
DeLand, Florida, United States, 32720
Site Reference ID/Investigator# 137990
Fort Pierce, Florida, United States, 34982
Site Reference ID/Investigator# 102935
Jacksonville, Florida, United States, 32256
Site Reference ID/Investigator# 136912
West Palm Beach, Florida, United States, 33401
United States, Illinois
Site Reference ID/Investigator# 95579
Chicago, Illinois, United States, 60612
United States, Maryland
Site Reference ID/Investigator# 95596
Baltimore, Maryland, United States, 21287
United States, Michigan
Site Reference ID/Investigator# 95588
East Lansing, Michigan, United States, 48824
United States, New Jersey
Site Reference ID/Investigator# 112537
Hillsborough, New Jersey, United States, 08844
Site Reference ID/Investigator# 95594
Newark, New Jersey, United States, 07102
United States, New York
Site Reference ID/Investigator# 95582
Bronx, New York, United States, 10468
United States, North Carolina
Site Reference ID/Investigator# 95586
Chapel Hill, North Carolina, United States, 27599
Site Reference ID/Investigator# 95597
Durham, North Carolina, United States, 27705
United States, Texas
Site Reference ID/Investigator# 95589
Dallas, Texas, United States, 75235
Site Reference ID/Investigator# 95595
Dallas, Texas, United States, 75246
Site Reference ID/Investigator# 95587
Houston, Texas, United States, 77004
United States, Virginia
Site Reference ID/Investigator# 102955
Lynchburg, Virginia, United States, 24501
United States, Washington
Site Reference ID/Investigator# 95600
Seattle, Washington, United States, 98101
Australia
Site Reference ID/Investigator# 124572
Adelaide, Australia, 5000
Site Reference ID/Investigator# 124570
Darlinghurst, Australia, 2010
Site Reference ID/Investigator# 124571
Melbourne, Australia, 3004
Canada
Site Reference ID/Investigator# 124575
Hamilton, Canada, L8V 1C3
Site Reference ID/Investigator# 124576
Vancouver, Canada, V6Z 1Y6
Site Reference ID/Investigator# 124574
Vancouver, Canada, V6Z 2C7
France
Site Reference ID/Investigator# 124577
Lyon, France, 69004
Site Reference ID/Investigator# 124579
Marseilles, France, 13009
Site Reference ID/Investigator# 124578
Paris, France, 75012
Site Reference ID/Investigator# 124582
Paris, France, 75020
Site Reference ID/Investigator# 124581
Paris, France, 75877
Germany
Site Reference ID/Investigator# 124583
Berlin, Germany, 10439
Site Reference ID/Investigator# 124587
Bonn, Germany, 53127
Site Reference ID/Investigator# 124586
Duesseldorf, Germany, 40237
Site Reference ID/Investigator# 124588
Hamburg, Germany, 20099
Site Reference ID/Investigator# 124584
Wuerzburg, Germany, 97080
Italy
Site Reference ID/Investigator# 124594
Milan, Italy, 20127
Site Reference ID/Investigator# 124596
Milan, Italy, 20157
New Zealand
Site Reference ID/Investigator# 124515
Auckland, New Zealand, 1023
Puerto Rico
Site Reference ID/Investigator# 95578
Bayamon, Puerto Rico, 00959
Site Reference ID/Investigator# 95575
Ponce, Puerto Rico, 00717-1563
Site Reference ID/Investigator# 95577
Ponce, Puerto Rico, 00731
Russian Federation
Site Reference ID/Investigator# 124605
Krasnoyarsk, Russian Federation, 660049
Site Reference ID/Investigator# 124606
Moscow, Russian Federation, 105275
Site Reference ID/Investigator# 124603
Saint-Petersburg, Russian Federation, 190103
Spain
Site Reference ID/Investigator# 124608
Alicante, Spain, 03010
Site Reference ID/Investigator# 124609
Barcelona, Spain, 08916
Site Reference ID/Investigator# 124607
Madrid, Spain, 28022
Site Reference ID/Investigator# 124610
San sebastian, Spain, 20014
United Kingdom
Site Reference ID/Investigator# 124612
Edinburgh, United Kingdom, EH4 2XU
Site Reference ID/Investigator# 124614
London, United Kingdom, E1 1BB
Site Reference ID/Investigator# 124611
London, United Kingdom, NW3 2QG
Site Reference ID/Investigator# 124613
London, United Kingdom, SW10 9NH
Site Reference ID/Investigator# 124615
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Rolando Viani, MD AbbVie
  More Information

Additional Information:
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: November 1, 2016
Health Authority: Spain: Ethics Committee
United States: Food and Drug Administration
New Zealand: Medsafe
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: The Italian Medicines Agency
France: Ministry of Health
United Kingdom: Research Ethics Committee
New Zealand: Ethics Committee
Australia: Human Research Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Virus Diseases
Hepatitis C
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Fibrosis
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ribavirin
Ritonavir
Antimetabolites

ClinicalTrials.gov processed this record on December 02, 2016