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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 180
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Intervention: Peg-Interferon Alpha-2A (Drug)
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Intervention: Ribavirin (Drug)
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Intervention: Peg-Interferon Alpha-2A (Drug)
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Intervention: Ribavirin (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR)
Time Frame: 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)
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.
Secondary Outcomes
- 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 CD4/CD8 Ratio 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)
- 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))
- 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)
- 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)
- Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories(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)