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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761629
• Other study ID #: ML18473
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2016
• Last updated: May 4, 2016
• Start date: April 2006
• Est. completion date: November 2009

Study information

• Verified date: May 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency (ANVISA)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (less than [<] 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Peg-Interferon Alpha-2A
Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.
• Ribavirin
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 <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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Sustained Virologic Response 24 Weeks After Completion of Study Treatment, as Assessed by Roche COBAS AMPLICOR HCV Test		Up to Week 96	No
Secondary	Percentage of Participants with Undetectable HCV RNA, as Assessed by Roche COBAS AMPLICOR HCV Test		Weeks 4, 12, 24, 48, and 72	No
Secondary	Percentage of Participants with Adverse Events (AEs)		Baseline up to Week 96	No
Secondary	Percentage of Participants with Undetectable HCV RNA 12 Weeks after the Last Dose of Peg-IFN-Alpha-2A, as Assessed by Roche COBAS AMPLICOR HCV Test		Up to Week 84	No
Secondary	Percentage of Participants without Sustained Virologic Response among Participants with Undetectable HCV RNA at the End of Treatment, as Assessed by Roche COBAS AMPLICOR HCV Test		Up to Week 96	No
Secondary	Serum HIV RNA Levels, as Assessed by Roche AMPLICOR MONITOR HIV-1		Weeks 4, 24, 48, 72, and 96	No
Secondary	Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96		Baseline, Weeks 4, 24, 48, 72, and 96	No
Secondary	Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96		Baseline, Weeks 4, 24, 48, 72, and 96	No
Secondary	Alanine Aminotransferase (ALT) Levels		Weeks 4, 12, 24, 48, 72, and 96	No