Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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


  Outcome Measures
  Show All Outcome Measures

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 ]

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
  Hide Limitations and Caveats

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