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Trial record 55 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

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

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ClinicalTrials.gov Identifier: NCT02762383
Recruitment Status : Terminated (Low recruitment)
First Posted : May 4, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
HIV/HCV Coinfection Drug: Peginterferon Alfa-2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Peginterferon Alfa-2a
Participants will receive a low dose of peginterferon alfa-2a for 18 months.
Drug: Peginterferon Alfa-2
Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.
Other Name: Pegasys




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

Secondary Outcome Measures :
  1. Percentage of Participants with Histological Response According to Paired Biopsy [ Time Frame: At end of treatment (up to 18 months) ]
  2. HIV RNA Viral Load in Copies per Milliliter (copies/mL) [ Time Frame: At end of treatment (up to 18 months) ]
  3. Cluster of Differentiation (CD) 4 Cell Count in Cells per Microliter (cells/mcL) [ Time Frame: At end of treatment (up to 18 months) ]
  4. 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) ]
  5. Percentage of Participants with Biochemical Response According to Alanine Aminotransferase (ALT) Level [ Time Frame: At end of treatment (up to 18 months) ]
  6. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762383


Locations
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Belgium
Bruxelles, Belgium, 1000
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1090
Bruxelles, Belgium, 1200
Charleroi, Belgium, 6000
Edegem, Belgium, 2650
Gent, Belgium, 9000
Leuven, Belgium, 3000
Liege, Belgium, 4000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02762383     History of Changes
Other Study ID Numbers: ML18234
2004-002736-26 ( EudraCT Number )
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Coinfection
Infection
Virus Diseases
Parasitic Diseases
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs