Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus

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Roche

Status and phase

Completed
Phase 4

Conditions

Hepatitis C, Chronic

Treatments

Drug: Ribavirin
Drug: Peg-Interferon Alpha-2A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02761629
ML18473

Details and patient eligibility

About

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).

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks
Experimental group
Description:
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 48 weeks.
Treatment:
Drug: Peg-Interferon Alpha-2A
Drug: Ribavirin
Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Active Comparator group
Description:
Participants will receive Peg-IFN-Alpha-2A and ribavirin for 72 weeks.
Treatment:
Drug: Peg-Interferon Alpha-2A
Drug: Ribavirin

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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