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

NCT02762383 | Terminated Phase 3

• 2 other identifiers: ML182342004-002736-26
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  From Baseline to end of treatment (up to 18 months)

Secondary Outcomes (6)

• Percentage of Participants with Histological Response According to Paired Biopsy

  At end of treatment (up to 18 months)

• HIV RNA Viral Load in Copies per Milliliter (copies/mL)

  At end of treatment (up to 18 months)

• Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL)

  At end of treatment (up to 18 months)

• Percentage of Participants with Virological Response According to HCV RNA Viral Load

  At 6, 12, and 18 months during treatment, and at 24 weeks after end of treatment (up to 2 years overall)

• Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level

  At end of treatment (up to 18 months)

Study Arms (1)

Peginterferon Alfa-2a

EXPERIMENTAL

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

Drug: Peginterferon Alfa-2

Interventions

Peginterferon Alfa-2 DRUG

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

Also known as: Pegasys

Peginterferon Alfa-2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Unknown Facility

Brussels, 1000, Belgium

Location

Unknown Facility

Brussels, 1020, Belgium

Location

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Brussels, 1090, Belgium

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Charleroi, 6000, Belgium

Location

Unknown Facility

Edegem, 2650, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

MeSH Terms

Interventions

peginterferon alfa-2a

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 4, 2016
• Study Start: March 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 7, 2016

Record last verified: 2016-05

Locations

BE (10)