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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2016
• Main ID: NCT02762383
• Date of registration: 03/05/2016
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)
• Scientific title: A Pilot, Open-Label, Multicentre Study Evaluating the Long-Term Safety and Tolerability of a Low-Dose Peginterferon Alfa-2a Maintenance Monotherapy in Chronic Hepatitis C Patients Co-Infected With Human Immunodeficiency Virus and Who Do Not Respond to a Standard Regimen of Peginterferon Alfa-2a Plus Ribavirin
• Date of first enrolment: March 2005
• Target sample size: 19
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02762383
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/HCV Coinfection

Intervention(s)

Drug: Peginterferon Alfa-2

Primary Outcome(s)

Percentage of Participants with Adverse Events (AEs) [Time Frame: From Baseline to end of treatment (up to 18 months)]

Secondary Outcome(s)

HIV RNA Viral Load in Copies per Milliliter (copies/mL) [Time Frame: At end of treatment (up to 18 months)]

Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level [Time Frame: At end of treatment (up to 18 months)]

Percentage of Participants with Virological Response According to HCV RNA Viral Load [Time Frame: At 6, 12, and 18 months during treatment, and at 24 weeks after end of treatment (up to 2 years overall)]

Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL) [Time Frame: At end of treatment (up to 18 months)]

Percentage of Participants with Histological Response According to Paired Biopsy [Time Frame: At end of treatment (up to 18 months)]

Percentage of Participants with Sustained Biochemical Response According to ALT Level [Time Frame: At 24 weeks after end of treatment (up to 2 years overall)]

Secondary ID(s)

2004-002736-26

ML18234

Source(s) of Monetary Support

Please refer to primary and secondary sponsors