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Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C (HIVCOBOC-RGT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01925183
First Posted: August 19, 2013
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Markus Peck-Radosavljevic, Medical University of Vienna
Results First Submitted: December 18, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis C, Chronic
HIV
Interventions: Drug: Pegylated interferon alpha-2a
Drug: Ribavirin
Drug: Boceprevir

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
28 Weeks of Treatment Duration

All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.

Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection

Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally

Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally

48 Weeks of Treatment Duration

All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks

Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection

Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally

Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally


Participant Flow:   Overall Study
    28 Weeks of Treatment Duration   48 Weeks of Treatment Duration
STARTED   3   3 
COMPLETED   2   3 
NOT COMPLETED   1   0 
Adverse Event                1                0 



  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.
No text entered.

Reporting Groups
  Description
28 Weeks of Treatment Duration

All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.

Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection

Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally

Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally

48 Weeks of Treatment Duration

All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks

Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection

Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally

Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally

Total Total of all reporting groups

Baseline Measures
   28 Weeks of Treatment Duration   48 Weeks of Treatment Duration   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   6 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3 100.0%      3 100.0%      6 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  33.3%      1  16.7% 
Male      3 100.0%      2  66.7%      5  83.3% 


  Outcome Measures
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1.  Primary:   Proportion of Subjects With Sustained Virologic Response (SVR12)   [ Time Frame: Follow-up week 12 (FU12) ]

2.  Primary:   Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline (BL) to Follow-up week 12 (FU12) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Markus Peck-Radosavljevic (Principal Investigator)
Organization: Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
phone: +43 1 40400 ext 47440
e-mail: markus.peck@meduniwien.ac.at



Responsible Party: Markus Peck-Radosavljevic, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01925183     History of Changes
Other Study ID Numbers: HIVCOBOC-RGT
2012-005591-33 ( EudraCT Number )
First Submitted: August 15, 2013
First Posted: August 19, 2013
Results First Submitted: December 18, 2016
Results First Posted: February 9, 2017
Last Update Posted: March 16, 2017