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Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01482767
First received: November 28, 2011
Last updated: June 1, 2016
Last verified: June 2016
Results First Received: April 5, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Hepatitis C
Interventions: Drug: Pegylated-Interferon Alfa 2b (PEG-IFN)
Drug: Ribavirin (RBV)
Drug: Boceprevir (BOC)

  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
Participants were enrolled from May 2012 to December 2013 at 42 U.S. sites.

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
HCV Treatment-Naive (Group A) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
HCV Treatment-Experienced (Group B) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.

Participant Flow:   Overall Study
    HCV Treatment-Naive (Group A)     HCV Treatment-Experienced (Group B)  
STARTED     135     127  
COMPLETED     81     78  
NOT COMPLETED     54     49  
Death                 1                 1  
Withdrawal by Subject                 7                 5  
Lost to Follow-up                 12                 6  
Adverse Event                 0                 3  
Site closure                 22                 14  
Non-adherence to study requirements                 4                 7  
Alternate HCV treatment                 7                 8  
Ineligible                 0                 5  
Nurse error                 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.
All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).

Reporting Groups
  Description
HCV Treatment-Naive (Group A) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
HCV Treatment-Experienced (Group B) Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
Total Total of all reporting groups

Baseline Measures
    HCV Treatment-Naive (Group A)     HCV Treatment-Experienced (Group B)     Total  
Number of Participants  
[units: participants]
  135     122     257  
Age  
[units: years]
Median (Inter-Quartile Range)
  51  
  (44 to 57)  
  53  
  (49 to 57)  
  52  
  (47 to 57)  
Gender [1]
[units: participants]
     
Female     25     29     54  
Male     110     93     203  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     17     28     45  
Not Hispanic or Latino     117     93     210  
Unknown or Not Reported     1     1     2  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     2     2  
Asian     2     2     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     73     53     126  
White     57     58     115  
More than one race     2     2     4  
Unknown or Not Reported     1     5     6  
Region of Enrollment  
[units: participants]
     
United States     135     122     257  
Intravenous Drug Use History  
[units: participants]
     
Never     71     70     141  
Previously     64     52     116  
Cirrhosis Status at Screening [2]
[units: participants]
     
Cirrhotic     18     38     56  
Non-cirrhotic     117     84     201  
HCV RNA at Entry [3]
[units: log10 IU/mL]
Median (Inter-Quartile Range)
  6.7  
  (6.2 to 7.1)  
  6.9  
  (6.5 to 7.3)  
  6.8  
  (6.4 to 7.2)  
ART Regimen at Entry  
[units: participants]
     
EFV + 2 NRTIs     58     51     109  
RAL + 2 NRTIs     47     45     92  
LPV/RTV + 2 NRTIs     4     4     8  
ATV/RTV + 2 NRTIs     18     10     28  
DRV/RTV + 2 NRTIs     6     6     12  
Not on ART     2     6     8  
CD4 Cell Count at Entry [4]
[units: cells/mm^3]
Median (Inter-Quartile Range)
  646  
  (462 to 818)  
  622  
  (489 to 859)  
  625  
  (473 to 835)  
HIV-1 RNA Quantitation at Entry [5]
[units: participants]
     
Unquantifiable     133     113     246  
Quantifiable     0     9     9  
Unknown     2     0     2  
[1] Sex at birth.
[2] Liver cirrhosis was defined as cirrhosis identified by screening liver biopsy or screening FibroSure score greater than 0.74.
[3] Group A: Among n=134 participants with samples collected.
[4] Among n=133 Group A and n=120 Group B participants who had results available.
[5] Unquantifiable HIV-1 RNA was defined as below the lower limit of the assay (LLOQ). Abbott RealTime HIV-1 assay (LLOQ=40 copies/ml) or Roche COBAS Ampliprep/Taqman HIV-1 assay (LLOQ=20 copies/ml) was used.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)   [ Time Frame: 24 weeks after treatment discontinuation ]

2.  Secondary:   Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)   [ Time Frame: From study treatment dispensation to Week 72 ]

3.  Secondary:   Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)   [ Time Frame: 12 weeks after treatment discontinuation ]

4.  Secondary:   Percentage of Participants With HIV-1 Viral Load <50 Copies/mL   [ Time Frame: Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72 ]

5.  Secondary:   CD4+ T-Cell Count (CD4) Change From Baseline   [ Time Frame: Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72 ]

6.  Secondary:   Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits   [ Time Frame: Weeks (W) 4, 8, 12 ]

7.  Secondary:   Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits   [ Time Frame: Weeks (W) 16, 20, 24, and 28 ]

8.  Secondary:   Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs   [ Time Frame: From study treatment dispensation to Week 28 ]


  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
No text entered.


  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: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications of Results:
Sherman KE, Kang M, Sterling R, Umbleja T, Marks K, Alston-Smith B, Greaves W, Butt A. BIRTH: A Phase 3 Trial of Boceprevir/Pegylated Interferon/Ribavirin in HCV/HIV. IDWeek. San Diego, CA. October, 2015. [Abstract 903]

Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01482767     History of Changes
Other Study ID Numbers: A5294 (BIRTH)
11774 ( Registry Identifier: DAIDS ES )
ACTG 5294
BIRTH
Study First Received: November 28, 2011
Results First Received: April 5, 2016
Last Updated: June 1, 2016
Health Authority: United States: Food and Drug Administration