NCT00353418

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2006

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 15, 2010

Completed
Last Updated

August 3, 2010

Status Verified

July 1, 2010

Enrollment Period

2.8 years

First QC Date

July 17, 2006

Results QC Date

May 14, 2010

Last Update Submit

July 30, 2010

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

  • 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.

    Week 72

  • Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia

    Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.

    Up to Week 72

Secondary Outcomes (5)

  • Virological Response at End of Treatment Period

    Week 48

  • Virological Response at Weeks 4, 12 and 24

    Weeks 4, 12 and 24

  • Relapse of Virological Response

    Weeks 48 and 72

  • Rapid Virological Response (RVR) by Week 4

    Week 4

  • Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12

    Week 12

Study Arms (2)

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

EXPERIMENTAL
Drug: Peginterferon alfa-2aDrug: Ribavirin

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

ACTIVE COMPARATOR
Drug: Peginterferon alfa-2aDrug: Ribavirin

Interventions

Peginterferon alfa-2aDRUG

180 µg subcutaneously weekly for 48 weeks

Also known as: Pegasys
PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mgPEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg
RibavirinDRUG

800 mg orally daily for 48 weeks

Also known as: Copegus
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, ≥18 years of age
  • CHC genotype 1
  • Stable HIV-1 infection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22592094DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 3, 2010

Results First Posted

June 15, 2010

Record last verified: 2010-07