Clinical trial 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatitis C Virus Infection
Human Immunodeficiency Virus Infection
Chronic Hepatitis C
Compensated Cirrhosis and Non-cirrhotics
Keywords: HCV Genotype 4
Interferon-Free
Hepatitis C Genotype 1
Compensated Cirrhosis
Hepatitis C Genotype 4
HCV / HIV coinfection
Cirrhotic
Hepatitis C
HIV-1
HCV Genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants in Part 1a Achieving SVR12
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants in Part 1b Achieving SVR12
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period
timeFrame: up to 12 or 24 weeks, based on treatment duration
measure: Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period
timeFrame: up to 12 weeks
measure: Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period
timeFrame: up to 12 or 24 weeks, based on treatment duration
measure: Percentage of Participants in Part 1a With Relapse12
timeFrame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug
measure: Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall
timeFrame: up to 12 weeks after the last actual dose of study drug
measure: Percentage of Participants in Part 2 With Relapse12
timeFrame: up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug
measure: Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
timeFrame: 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)
measure: Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
timeFrame: End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)
measure: Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Rolando Viani, MD
role: STUDY_DIRECTOR
References:
citation: Sulkowski MS, Eron JJ, Wyles D, Trinh R, Lalezari J, Wang C, Slim J, Bhatti L, Gathe J, Ruane PJ, Elion R, Bredeek F, Brennan R, Blick G, Khatri A, Gibbons K, Hu YB, Fredrick L, Schnell G, Pilot-Matias T, Tripathi R, Da Silva-Tillmann B, McGovern B, Campbell AL, Podsadecki T. Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial. JAMA. 2015 Mar 24-31;313(12):1223-31. doi: 10.1001/jama.2015.1328.
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citation: King JR, Khatri A, Trinh R, Viani RM, Ding B, Zha J, Menon R. Pharmacokinetic Evaluation of Darunavir Administered Once or Twice Daily in Combination with Ritonavir or the Three-Direct-Acting Antiviral Regimen of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults Coinfected with Hepatitis C and Human Immunodeficiency Viruses. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e02135-16. doi: 10.1128/AAC.02135-16. Print 2017 Feb.
citation: Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.