Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Chronic Hepatitis C, Co-infection, Induction dose, HIV, HIV Infections
Eligibility 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.
Sites / Locations
- Hospital Germans Trias i Pujol, Badalona
- Consorci Sanitari de Terrassa
- Hospital General de Vic
- Hospital de Donostia
- Hospital General Universitario de Alicante
- Hospital del Mar
- Hospital Clínic i Provincial
- Hospital Puerta del Mar
- Hospital Gregorio Marañón.
- Hospital Ramón y Cajal
- Hospital Clínico San Carlos
- Hospital La Paz
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
A
B
Peginterferon alfa-2a (40 KD) (270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (40 KD) (180 µg/week) + Ribavirin (1000-1200 mg/day) for 8 weeks
Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks