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 - Full Text View

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Ritonavir Dasabuvir

U.S. FDA Resources

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


Estimated Enrollment:	320
Study Start Date:	August 2013
Estimated Study Completion Date:	October 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 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

Show 64 Study Locations

Sponsors and Collaborators

AbbVie

Investigators


Study Director:	Rolando Viani, MD	AbbVie

More Information

Additional Information:

This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferrière V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study. 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):919-26. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

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.


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 19, 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 Coinfection 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 Parasitic Diseases Ribavirin

ClinicalTrials.gov processed this record on September 27, 2016

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)