HIV Infections Clinical Trial
Official title:
Open, Multicentre and Randomised Phase IV Study to Evaluate Viral Kinetics in the First 12 Weeks of Patients With Chronic Hepatitis C Genotypes 1 and 4 Coinfected by the Human Immunodeficiency Virus Treated With Induction Doses of Peginterferon Alpha-2a (40 KD) (270 μg/Week) and Ribavirin (1600 mg/Day) With Epoetin β Support (450 IU/kg/Week)
The purpose of this study is to compare the early virological response (EVR = undetectable [ribonucleic acid-hepatitis C virus] RNA-HCV or a reduction of > 2 log10) of patients with chronic hepatitis C coinfected with HIV treated with induction doses of peginterferon alpha-2a (40 KD) 270 µg/week and ribavirin 1600 mg/day for 4 weeks, followed by 8 weeks of treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day versus treatment with peginterferon alpha-2a (40 KD) 180 µg/week and ribavirin 1000-1200 mg/day for 12 weeks.
This study seeks to ascertain whether treatment with higher doses of PEGASYS (270 µg/week)
and ribavirin (1600 mg/day) for the first four weeks achieves the plasma concentrations of
the product in the blood needed to reduce the half-life of the virions and accelerate the
elimination thereof. This would bring the viral kinetic curves in coinfected patients closer
to the model described for mono-infected HCV patients, probably achieving improved rates of
response in week 12 (early virological response) and posterior in week 72 (sustained
virological response).
Therefore, the patients were randomised to treatment with two different doses, 270 µg and 180
µg of PEGASYS, and 1600 mg and 1000-1200 mg of ribavirin.
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