Overview

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.