Status:
COMPLETED
Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborating Sponsors:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 hepatit...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00356486
Start Date
October 1 2005
End Date
March 1 2009
Last Update
December 4 2019
Active Locations (12)
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1
Hospital Germans Trias i Pujol, Badalona
Badalona, Barcelona, Spain, 08916
2
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08221
3
Hospital General de Vic
Vic, Barcelona, Spain, 08500
4
Hospital de Donostia
San Sebastián, Donostia, Spain, 20012