A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
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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. |
ClinicalTrials.gov Identifier: NCT00959699 |
Recruitment Status :
Completed
First Posted : August 17, 2009
Results First Posted : August 30, 2013
Last Update Posted : April 7, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, 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 |
Enrollment | 99 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 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. |
Arm/Group Title | PegIFN-2b + RBV | PegIFN-2b + RBV + Boceprevir |
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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 (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. |
Period Title: Treatment Period | ||
Started | 34 | 65 |
Treated | 34 | 64 |
Completed | 11 [1] | 40 |
Not Completed | 23 | 25 |
Reason Not Completed | ||
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.
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Period Title: Follow-up Period | ||
Started | 33 [1] | 62 [2] |
Completed | 27 | 56 |
Not Completed | 6 | 6 |
Reason Not Completed | ||
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.
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Baseline Characteristics
Arm/Group Title | PegIFN-2b + RBV | PegIFN-2b + RBV + Boceprevir | Total | |
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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 (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 of all reporting groups | |
Overall Number of Baseline Participants | 34 | 64 | 98 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 34 participants | 64 participants | 98 participants | |
45.1 (9.8) | 42.9 (8.3) | 43.6 (8.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 64 participants | 98 participants | |
Female |
12 35.3%
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18 28.1%
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30 30.6%
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Male |
22 64.7%
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46 71.9%
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68 69.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 Investigator must provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc.) that report any results of the trial. The sponsor shall have the right to review and comment.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme Corp. |
EMail: | ClinicalTrialsDisclosure@merck.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00959699 |
Other Study ID Numbers: |
P05411 MK-3034-025 ( Other Identifier: Merck study number ) |
First Submitted: | July 29, 2009 |
First Posted: | August 17, 2009 |
Results First Submitted: | May 8, 2013 |
Results First Posted: | August 30, 2013 |
Last Update Posted: | April 7, 2017 |