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A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and Efficacy of Pegasys 180 µg plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 µg plus ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005506-23

A Randomized, Multicenter, Double Blinded, Phase IV Study Comparing the Safety and Efficacy of Pegasys 180 µg plus Copegus 1000 or 1200 mg to the Currently Approved Combination of Pegasys 180 µg plus Copegus 800 mg in Interferon-naïve Patients with Chronic Hepatitis C Genotype 1 virus infection coinfected with human immunodeficiency virus (HIV-1)

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Extrait

Primary Efficacy • To compare the efficacy of treatment with Copegus (ribavirin (RBV)) 1000 or 1200 mg in combination with Pegasys (peginterferon alfa-2a (PEG-IFN alfa-2a)) 180 µg to the approved regimen of Copegus 800 mg in combination with Pegasys 180 µg in patients with chronic hepatitis C genotype 1 virus coinfected with HIV-1 treated for 48 weeks and followed for 24 weeks after treatment end (sustained virologic response, SVR) Primary Safety • To compare the safety of treatment with Copegus 1000 or 1200 mg in combination with Pegasys 180 µg to the approved regimen of Copegus 800 mg in combination with Pegasys 180 µg in patients with chronic hepatitis C genotype 1 virus coinfected with HIV-1 treated for 48 weeks and followed for 24 weeks after treatment end

Critère d'inclusion

  • Patients with chronic hepatitis C (CHC) genotype 1 virus coinfected with human immunodeficiency virus type 1 (HIV-1)

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