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A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00959699
First received: July 29, 2009
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Hepatitis C
HCV Infection
Interventions: Drug: PegIFN-2b
Drug: RBV
Drug: Placebo to Boceprevir
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
One participant in the pegylated interferon alfa-2b (PegIFN-2b) + ribavirin (RBV) + boceprevir group withdrew from the study after randomization but prior to administration of any study treatment.

Reporting Groups
  Description
PegIFN-2b + RBV PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b + RBV + Boceprevir PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.

Participant Flow for 2 periods

Period 1:   Treatment Period
    PegIFN-2b + RBV     PegIFN-2b + RBV + Boceprevir  
STARTED     34     65  
Treated     34     64  
COMPLETED     11 [1]   40  
NOT COMPLETED     23     25  
Adverse Event                 3                 13  
Lack of Efficacy                 15                 6  
Lost to Follow-up                 0                 1  
Withdrawal by Subject                 1                 3  
Non-Compliance with Protocol                 0                 1  
Did not receive treatment                 0                 1  
Futility/crossover to boceprevir                 4                 0  
[1] At TW24, 4 participants not achieving undetectable HCV-RNA crossed-over and received boceprevir.

Period 2:   Follow-up Period
    PegIFN-2b + RBV     PegIFN-2b + RBV + Boceprevir  
STARTED     33 [1]   62 [2]
COMPLETED     27     56  
NOT COMPLETED     6     6  
Lost to Follow-up                 3                 2  
Withdrawal by Subject                 3                 4  
[1] 1 participant didn't enter Follow-up; participants discontinuing treatment could enter Follow-up.
[2] 2 participants didn't enter Follow-up; participants discontinuing treatment could enter Follow-up.



  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
PegIFN-2b + RBV PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b + RBV + Boceprevir PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
Total Total of all reporting groups

Baseline Measures
    PegIFN-2b + RBV     PegIFN-2b + RBV + Boceprevir     Total  
Number of Participants  
[units: participants]
  34     64     98  
Age  
[units: years]
Mean ± Standard Deviation
  45.1  ± 9.8     42.9  ± 8.3     43.6  ± 8.8  
Gender  
[units: participants]
     
Female     12     18     30  
Male     22     46     68  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication   [ Time Frame: Up to Week 72 ]

2.  Secondary:   Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)   [ Time Frame: Up to Week 72 ]

3.  Secondary:   Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24   [ Time Frame: Up to Week 12 ]

4.  Secondary:   Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)   [ Time Frame: Up to Week 60 ]

5.  Secondary:   Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)   [ Time Frame: Baseline and Week 4 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
Measure Description This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Time Frame Baseline and Week 4  
Safety Issue No  

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 randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.

Reporting Groups
  Description
PegIFN-2b + RBV PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
PegIFN-2b + RBV + Boceprevir PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.

Measured Values
    PegIFN-2b + RBV     PegIFN-2b + RBV + Boceprevir  
Number of Participants Analyzed  
[units: participants]
  34     64  
Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)  
[units: participants]
   
Participants with <1 positive log drop     15     28  
Participants with >= 1 positive log drop     16     32  
Participants with undetectable HCV-RNA     3     3  
Participants with missing data     0     1  

No statistical analysis provided for Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)



6.  Secondary:   Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound   [ Time Frame: Up 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