Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Collaborators: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Epoetin Alfa; Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Serological evidence of chronic hepatitis C infection in an anti-HCV antibody test

• Detectable RNA-HCV plasma level genotype 1 and 4

• ALT serum activity above the upper limit of normality

• Chronic liver disease consistent with chronic hepatitis C infection in a biopsy obtained during the two years prior to inclusion in the study

• Serological evidence of HIV-1 infection, diagnosed by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed by Western-blot.

• Patients with CD4 cell count > 200 /µl

• Stable status in HIV-1 infection, in the investigator's opinion, in other words, patients that are not expected to progress during the study.

• Patients treated with stable anti-retroviral therapy (HAART), which does not include nucleoside analogues, for at least 6 weeks before the baseline assessment

• Patients that do not receive HAART therapy

• Negative pregnancy test in urine or blood

Exclusion Criteria:

• Women currently pregnant or in the lactation period.

• Patients whose companion is pregnant.

• Therapy with interferon (IFN) or ribavirin at any previous time.

• Patients with cirrhosis in the hepatic biopsy.

• Documented suspicion by ultrasound of hepatocarcinoma.