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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Percentage of Participants with Adverse Events (AEs)
Time frame: From Baseline to 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)
HIV RNA Viral Load in Copies per Milliliter (copies/mL)
Time frame: At end of treatment (up to 18 months)
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 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)
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 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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Unnamed facility
Brussels, Belgium
Unnamed facility
Charleroi, Belgium
Unnamed facility
Edegem, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Liège, Belgium