A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01479868
First received: October 18, 2011
Last updated: October 28, 2014
Last verified: October 2014
Results First Received: August 26, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C Virus Genotype-1
Interventions: Drug: TMC435
Drug: Pegylated interferon alpha-2a
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TMC435 150mg 12Wks PR24/48 Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Participant Flow:   Overall Study
    TMC435 150mg 12Wks PR24/48  
STARTED     106 [1]
COMPLETED     97  
NOT COMPLETED     9  
Adverse Event                 1  
Lost to Follow-up                 4  
Protocol Violation                 1  
Withdrawal by Subject                 1  
Sponsor's Decision                 1  
Initiation of new HCV Therapy                 1  
[1] Restricted to subject who received at least one dose of treatment (TMC435/RBV/PegIFN).



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population included all participants who received at least 1 dose of study drug.

Reporting Groups
  Description
TMC435 150mg 12Wks PR24/48 Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Baseline Measures
    TMC435 150mg 12Wks PR24/48  
Number of Participants  
[units: participants]
  106  
Age  
[units: years]
Median ( Full Range )
  48  
  ( 27 to 67 )  
Gender  
[units: participants]
 
Female     16  
Male     90  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)   [ Time Frame: 12 weeks after end of treatment (Week 24 or 48) ]

2.  Secondary:   Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)   [ Time Frame: 24 weeks after end of treatment (Week 24 or 48) ]

3.  Secondary:   Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable   [ Time Frame: Week 4, 12, 24, 36, and 48 ]

4.  Secondary:   Percentage of Participants With On-treatment Failure   [ Time Frame: Week 1 to 48 ]

5.  Secondary:   Percentage of Participants With Viral Breakthrough   [ Time Frame: Week 1 to 48 ]

6.  Secondary:   Percentage of Participants With Viral Relapse   [ Time Frame: Week 1 to 72 ]

7.  Secondary:   Percentage of Participants With Normalized Alanine Aminotransferase Levels   [ Time Frame: Baseline up to Week 72 ]

8.  Secondary:   Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure   [ Time Frame: Baseline to Week 72. ]

9.  Secondary:   Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load   [ Time Frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72 ]

10.  Secondary:   Mean Change From Baseline in CD4+ Cell Count   [ Time Frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72 ]

11.  Secondary:   Change From Baseline in CD4+ Cell Count in Percentage   [ Time Frame: Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72 ]

12.  Secondary:   Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)   [ Time Frame: Week 1 to Week 72 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director & Study Responsible Scientist
Organization: Janssen Research & Development
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided by Janssen R&D Ireland

Publications automatically indexed to this study:

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01479868     History of Changes
Obsolete Identifiers: NCT01727323
Other Study ID Numbers: CR018334, TMC435-TiDP16-C212
Study First Received: October 18, 2011
Results First Received: August 26, 2014
Last Updated: October 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Ethics Commission