Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus
Randomized, Multi-Center, Phase IV, Comparative Study to Assess the Efficacy and Safety of Combined Peg-Interferon Alpha-2a (40 kD) With Ribavirin Combined Therapy for 48 or 72 Weeks of Treatment and 24 Weeks of Follow-Up in Patients With Chronic Hepatitis C, Genotype 1, Co-Infected With Human Immunodeficiency Virus
1 other identifier
interventional
180
1 country
17
Brief Summary
This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2005
Typical duration for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedResults Posted
Study results publicly available
August 16, 2016
CompletedAugust 16, 2016
July 1, 2016
3.1 years
May 3, 2016
July 5, 2016
July 5, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response (SVR)
SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter \[IU/mL\]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.
24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
Secondary Outcomes (7)
Percentage of Participants With Undetectable HCV RNA
For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, and 48; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, and 72
Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A
12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 84 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment
24 weeks after completion of study treatment (up to Week 72 for "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm and up to Week 96 for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm)
Serum Human Immunodeficiency Virus (HIV) RNA Levels
For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Weeks 4, 12, 24, 48, 72, and 96
Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
For "Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, and 72; for "Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks" arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96
- +2 more secondary outcomes
Study Arms (2)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
EXPERIMENTALParticipants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
ACTIVE COMPARATORParticipants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Interventions
Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.
Ribavirin will be administered as either 1000 milligrams (mg) (2\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing less than (\<) 75 kilograms (kg) or as 1200 mg (3\*200 mg tablets in morning and 3\*200 mg tablets in evening) for participants weighing greater than or equal to (\>/=) 75 kg.
Eligibility Criteria
You may qualify if:
- Serological evidence of chronic hepatitis C infection by anti-hepatitis C virus (HCV) test
- Detectable HCV-ribonucleic acid (RNA) plasma level testing by Roche AMPLICOR HCV (\<50 International Units per milliliter \[IU/mL\]) (qualitative test)
- Chronic liver disease consistent with infection of CHC
- Compensated liver disease (Child-Pugh Grade A)
- Serological evidence of infection by HIV-1 test, anti-HIV-1 or HIV-1 RNA detection
- Negative pregnancy urine or blood test (for women in childbearing age); additionally, all men and women of childbearing potential must agree to use two effective forms of contraception during the treatment and during the 6 months after the end of treatment
You may not qualify if:
- Pregnant or nursing women and male partners of pregnant women
- Prior therapy with interferon (IFN) or ribavirin and any investigational medication less than or equal to (\</=) 6 weeks before the first dose of the study drug
- History or other evidence of a medical condition associated with chronic liver disease further than HCV
- Active opportunistic infection associated with HIV and / or cancer requiring systemic therapy
- History of any other significant illness which in the investigator's opinion, could result in the participant's inability to meet the Protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Campinas, 13081-970, Brazil
Unknown Facility
Florianópolis, 88032-001, Brazil
Unknown Facility
Itajaí, 88302-202, Brazil
Unknown Facility
Juiz de Fora, 36036-330, Brazil
Unknown Facility
Porto Alegre, 90020-160, Brazil
Unknown Facility
Recife, 52050-150, Brazil
Unknown Facility
Ribeirão Preto, 14048-900, Brazil
Unknown Facility
Rio de Janeiro, 20270-901, Brazil
Unknown Facility
Rio de Janeiro, 21045-900, Brazil
Unknown Facility
Rio de Janeiro, 21941-590, Brazil
Unknown Facility
Rio Grande, 96200-310, Brazil
Unknown Facility
Santo André, 09060-650, Brazil
Unknown Facility
Santos, 11045-904, Brazil
Unknown Facility
São Paulo, 01246-000, Brazil
Unknown Facility
São Paulo, 04039-004, Brazil
Unknown Facility
São Paulo, 04040-002, Brazil
Unknown Facility
São Paulo, 05403, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-La Roche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 4, 2016
Study Start
April 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
August 16, 2016
Results First Posted
August 16, 2016
Record last verified: 2016-07