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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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Ribavirin
Ribavirin
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients, ≥18 years of age CHC genotype 1 Stable HIV-1 infection Exclusion Criteria: Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors Medical condition associated with liver disease other than CHC infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg

    PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    Sustained Virological Response (SVR)
    SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
    Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
    Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.

    Secondary Outcome Measures

    Virological Response at End of Treatment Period
    Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
    Virological Response at Weeks 4, 12 and 24
    Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
    Relapse of Virological Response
    Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
    Rapid Virological Response (RVR) by Week 4
    RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
    Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
    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.

    Full Information

    First Posted
    July 17, 2006
    Last Updated
    July 30, 2010
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00353418
    Brief Title
    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
    Official Title
    A Randomized, Multicenter, Double Blinded Study Comparing the Safety and Efficacy of Pegasys® 180 ug Plus Copegus® 1000 or 1200 mg to the Currently Approved Combination of Pegasys® 180 ug Plus Copegus® 800 mg in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection and HIV-1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hoffmann-La Roche

    4. Oversight

    5. Study Description

    Brief Summary
    This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    415 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg
    Arm Type
    Experimental
    Arm Title
    PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Peginterferon alfa-2a
    Other Intervention Name(s)
    Pegasys
    Intervention Description
    180 µg subcutaneously weekly for 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    Copegus
    Intervention Description
    800 mg orally daily for 48 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    Copegus
    Intervention Description
    1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
    Primary Outcome Measure Information:
    Title
    Sustained Virological Response (SVR)
    Description
    SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
    Time Frame
    Week 72
    Title
    Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
    Description
    Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
    Time Frame
    Up to Week 72
    Secondary Outcome Measure Information:
    Title
    Virological Response at End of Treatment Period
    Description
    Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
    Time Frame
    Week 48
    Title
    Virological Response at Weeks 4, 12 and 24
    Description
    Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
    Time Frame
    Weeks 4, 12 and 24
    Title
    Relapse of Virological Response
    Description
    Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
    Time Frame
    Weeks 48 and 72
    Title
    Rapid Virological Response (RVR) by Week 4
    Description
    RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
    Time Frame
    Week 4
    Title
    Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients, ≥18 years of age CHC genotype 1 Stable HIV-1 infection Exclusion Criteria: Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin, amantadine or investigational HCV protease or polymerase inhibitors Medical condition associated with liver disease other than CHC infection
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22592094
    Citation
    Rodriguez-Torres M, Slim J, Bhatti L, Sterling R, Sulkowski M, Hassanein T, Serrao 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. doi: 10.1310/hct1303-142.
    Results Reference
    derived
    Links:
    URL
    http://www.roche-trials.com/studyResultGet.action?studyResultNumber=NV18209
    Description
    Clinical Study Report Synopsis

    Learn more about this trial

    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

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