Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
Information source: Germans Trias i Pujol Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Peginterferon alfa-2a, Ribavirin, epoetin-β (Drug); Peginterferon alfa-2a + Ribavirin for 12 weeks (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Germans Trias i Pujol Hospital Official(s) and/or principal investigator(s):
Bonaventura Clotet, MD, PhD, Principal Investigator, Affiliation: LLuita contra la Sida Foundation-HIV Unit
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.
Clinical Details
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)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients with undetectable RNA-HCV
Secondary outcome: Variations of the levels of RNA-HCVPercentage of patients with undetectable HCV RNA Levels of ALT Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin. Percentage of patients that drop out of the study for adverse effects or intolerance Variations in levels of haemoglobin, neutrophil, and platelet count AIDS-defining events or death Changes in the CD4/CD8 cell count
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Hospital General Universitario de Alicante, Alicante 46014, Spain
Hospital del Mar, Barcelona 08003, Spain
Hospital Clinic i Provincial, Barcelona 08036, Spain
Hospital Puerta del Mar, Cádiz 1009, Spain
Hospital La Paz, Madrid, Spain
Hospital Ramón y Cajal, Madrid 28007, Spain
Hospital Gregorio Marañón., Madrid 28007, Spain
Hospital Clínico San Carlos, Madrid 28040, Spain
Hospital Germans Trías i Pujol, Badalona, Badalona, Barcelona 08916, Spain
Hospital de Vic, Vic, Barcelona 08500, Spain
Consorci Sanitari de Terrassa, Tarrassa, Barcelona 08221, Spain
Hospital de Donostia, San Sebastián, Donostia 20012, Spain
Additional Information
Starting date: October 2005
Ending date: December 2008
Last updated: February 19, 2008
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