Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV

This study has been terminated.
(Unable to complete enrollment due to newly approved treatment options.)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01443923
First received: September 29, 2011
Last updated: July 9, 2015
Last verified: July 2015
Results First Received: February 25, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis
HIV/AIDS
Interventions: Drug: Boceprevir
Drug: Peg-Interferon-alfa 2B
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
1-HCV

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

2 HCV/HIV

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin


Participant Flow:   Overall Study
    1-HCV     2 HCV/HIV  
STARTED     3     1  
COMPLETED     2     1  
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.
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Reporting Groups
  Description
1-HCV

Hepatitis C Mono-infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

2 HCV/HIV

Hepatitis C and HIV co-Infected

Boceprevir

Peg-Interferon-alfa 2B

Ribavirin

Total Total of all reporting groups

Baseline Measures
    1-HCV     2 HCV/HIV     Total  
Number of Participants  
[units: participants]
  3     1     4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     1     4  
>=65 years     0     0     0  
Age  
[units: Years]
Mean (Standard Deviation)
  58  (3)     56  (0)     57.5  (2.64575)  
Gender  
[units: participants]
     
Female     1     0     1  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     3     1     4  



  Outcome Measures
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1.  Primary:   Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.   [ Time Frame: 6 months post treatment ]

2.  Secondary:   Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects   [ Time Frame: Day 0, Day 7 ]

3.  Secondary:   Safety and Treatment Outcome Measures Stratified by ESA Use   [ Time Frame: 6 months ]

4.  Secondary:   Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment   [ Time Frame: End of Treatment ]

5.  Secondary:   Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects   [ Time Frame: 6 months post treatment ]


  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: Dr. Shyam Kottilil
Organization: NIAID/NIH
phone: 301-435-0936
e-mail: skottilil@niaid.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01443923     History of Changes
Other Study ID Numbers: 110253, 11-I-0253
Study First Received: September 29, 2011
Results First Received: February 25, 2015
Last Updated: July 9, 2015
Health Authority: United States: Federal Government