A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00353418

First received: July 17, 2006

Last updated: July 30, 2010

Last verified: July 2010

History of Changes

Results First Received: May 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hepatitis C, Chronic
Interventions:	Drug: Peginterferon alfa-2a Drug: Ribavirin

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
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Reporting Groups

	Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg	No text entered.

Participant Flow: Overall Study

	PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
STARTED	138	277
COMPLETED	55	119
NOT COMPLETED	83	158

Baseline Characteristics

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Reporting Groups

	Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg	No text entered.
Total	Total of all reporting groups

Baseline Measures

	PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg	Total
Number of Participants [units: participants]	138	277	415
Age, Customized ^[1] [units: Participants]
< 65 years	134	273	407
>=65 years	1	2	3
Age ^[1] [units: Years] Mean ± Standard Deviation	45.2 ± 8.39	45.5 ± 8.16	45.4 ± 8.24
Gender ^[1] [units: Participants]
Female	29	51	80
Male	106	224	330

[1]	The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.

Outcome Measures

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1. Primary:

Sustained Virological Response (SVR) [ Time Frame: Week 72 ]

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2. Primary:

Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia [ Time Frame: Up to Week 72 ]

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3. Secondary:

Virological Response at End of Treatment Period [ Time Frame: Week 48 ]

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4. Secondary:

Virological Response at Weeks 4, 12 and 24 [ Time Frame: Weeks 4, 12 and 24 ]

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5. Secondary:

Relapse of Virological Response [ Time Frame: Weeks 48 and 72 ]

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6. Secondary:

Rapid Virological Response (RVR) by Week 4 [ Time Frame: Week 4 ]

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7. Secondary:

Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 [ Time Frame: Week 12 ]

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Measure Type	Secondary
Measure Title	Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
Measure Description	EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.
Time Frame	Week 12
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.
The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.

Reporting Groups

	Description
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	No text entered.
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg	No text entered.

Measured Values

	PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg	PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Number of Participants Analyzed [units: participants]	135	275
Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12 [units: Percentage of participants]
Early Virological Response	51	61
Partial Early Virological Response	25	35
Complete Early Virological Response	26	26

No statistical analysis provided for Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12

Serious Adverse Events

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Other Adverse Events

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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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

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
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrão R, Sola R, Bertasso A, Passe And S, Stancic S. Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. HIV Clin Trials. 2012 May-Jun;13(3):142-52.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353418 History of Changes
Other Study ID Numbers:	NV18209
Study First Received:	July 17, 2006
Results First Received:	May 14, 2010
Last Updated:	July 30, 2010
Health Authority:	United States: Food and Drug Administration

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