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: March 9, 2017

Last verified: March 2017

History of Changes

Results First Received: May 8, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: 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

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
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.
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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
Overall Participants Analyzed [Units: Participants]	34	64	98

Age [Units: Years] Mean (Standard Deviation)	45.1 (9.8)	42.9 (8.3)	43.6 (8.8)

Sex: Female, Male [Units: Participants] Count of Participants
Female	12 35.3%	18 28.1%	30 30.6%
Male	22 64.7%	46 71.9%	68 69.4%

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 ]

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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 ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4) [ Time Frame: Baseline and Week 4 ]

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6. Secondary:

Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound [ Time Frame: Up to Week 72 ]

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Serious Adverse Events

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Other Adverse Events

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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:

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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.
e-mail: ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sulkowski M, Pol S, Mallolas J, Fainboim H, Cooper C, Slim J, Rivero A, Mak C, Thompson S, Howe AY, Wenning L, Sklar P, Wahl J, Greaves W; P05411 study investigators. Boceprevir versus placebo with pegylated interferon alfa-2b and ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a randomised, double-blind, controlled phase 2 trial. Lancet Infect Dis. 2013 Jul;13(7):597-605. doi: 10.1016/S1473-3099(13)70149-X. Epub 2013 Jun 12.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00959699 History of Changes
Other Study ID Numbers:	P05411 MK-3034-025 ( Other Identifier: Merck study number )
Study First Received:	July 29, 2009
Results First Received:	May 8, 2013
Last Updated:	March 9, 2017

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