Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)

NCT ID: NCT02762383

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-06-30

Brief Summary

This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.

Conditions

HIV/HCV Coinfection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon Alfa-2a

Participants will receive a low dose of peginterferon alfa-2a for 18 months.

Group Type: EXPERIMENTAL

Peginterferon Alfa-2

Intervention Type: DRUG

Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.

Interventions

Peginterferon Alfa-2

Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.

Intervention Type: DRUG

Other Intervention Names

Pegasys

Eligibility Criteria

Inclusion Criteria

• Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
• Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
• Detectable serum HCV RNA at Screening
• Serologic evidence of HIV infection by HIV RNA detection
• CD4 cell count greater than or equal to (>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
• Stable HIV status and, if on antiretroviral therapy, a stable regimen for at least 6 weeks prior to Baseline
• Compensated liver disease
• No evidence of hepatocellular carcinoma

Exclusion Criteria

• Pregnant or breastfeeding
• Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
• Any investigational drug within 6 weeks prior to first dose
• Positive for hepatitis A immunoglobulin M antibody
• Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
• Severe psychiatric or neurologic comorbidity
• History of any significant medical conditions, such as immune disorders or disease of the major organ systems
• Uncontrolled thyroid disease
• Severe retinopathy
• Evidence of drug abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Charleroi, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Countries

Belgium

Other Identifiers

2004-002736-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML18234

Identifier Type: -

Identifier Source: org_study_id