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

December 3, 2019 updated by: Germans Trias i Pujol Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 46014
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Cádiz, Spain, 11009
        • Hospital Puerta del Mar
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón.
      • Madrid, Spain, 28007
        • Hospital Ramon y Cajal
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol, Badalona
      • Terrassa, Barcelona, Spain, 08221
        • Consorci Sanitari de Terrassa
      • Vic, Barcelona, Spain, 08500
        • Hospital General de Vic
    • Donostia
      • San Sebastián, Donostia, Spain, 20012
        • Hospital de Donostia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Drug: Peginterferon alfa-2a, Ribavirin, epoetin-β
Peginterferon alfa-2a(270 µg/week) + Ribavirin (1600 mg/day) + epoetin-β (450 UI/kg/week) for 4 weeks. Peginterferon alfa-2a (180 µg/week) + Ribavirin(1000-1200 mg/day) for 8 weeks
Experimental: B
Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
Drug: Peginterferon alfa-2a + Ribavirin for 12 weeks
Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with undetectable RNA-HCV
Time Frame: at week 12 after starting treatment
at week 12 after starting treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Variations of the levels of RNA-HCV
Time Frame: from baseline until weeks 4, 8, and 12 of the study
from baseline until weeks 4, 8, and 12 of the study
Percentage of patients with undetectable HCV RNA
Time Frame: in weeks 4 and 8 of the study
in weeks 4 and 8 of the study
Levels of ALT
Time Frame: At weeks 4, 8, and 12
At weeks 4, 8, and 12
Percentage of patients that must reduce the dose of peginterferon alpha-2a (40 KD) and ribavirin.
Time Frame: During the 12 weeks of follow-up
During the 12 weeks of follow-up
Percentage of patients that drop out of the study for adverse effects or intolerance
Time Frame: During the 12 weeks of follow-up
During the 12 weeks of follow-up
Variations in levels of haemoglobin, neutrophil, and platelet count
Time Frame: at 4, 8, and 12 weeks with regard to baseline
at 4, 8, and 12 weeks with regard to baseline
AIDS-defining events or death
Time Frame: During the 12 weeks of follow-up
During the 12 weeks of follow-up
Changes in the CD4/CD8 cell count
Time Frame: At 4, 8, and 12 weeks of follow-up
At 4, 8, and 12 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Collaborators

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORAL-2
  • 2004 - 000907 -16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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