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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Peginterferon alfa-2a, Ribavirin, epoetin-β
Peginterferon alfa-2a + Ribavirin for 12 weeks
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of patients with undetectable RNA-HCV

Secondary Outcome Measures

Variations of the levels of RNA-HCV
Percentage 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

Full Information

First Posted
July 25, 2006
Last Updated
December 3, 2019
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
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1. Study Identification

Unique Protocol Identification Number
NCT00356486
Brief Title
Viral Kinetics of Treatment With Peginterferon Alpha-2a, Ribavirin and Epoetin β in Patients Coinfected HCV/HIV
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 Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Chronic Hepatitis C, Co-infection, Induction dose, HIV, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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
Arm Title
B
Arm Type
Experimental
Arm Description
Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a, Ribavirin, epoetin-β
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a + Ribavirin for 12 weeks
Intervention Description
Peginterferon alfa-2a (40 KD) (180 µg/week) subcutaneous + Ribavirin(1000-1200 mg/day) oral/day for 12 weeks
Primary Outcome Measure Information:
Title
Percentage of patients with undetectable RNA-HCV
Time Frame
at week 12 after starting treatment
Secondary Outcome Measure Information:
Title
Variations of the levels of RNA-HCV
Time Frame
from baseline until weeks 4, 8, and 12 of the study
Title
Percentage of patients with undetectable HCV RNA
Time Frame
in weeks 4 and 8 of the study
Title
Levels of ALT
Time Frame
At weeks 4, 8, and 12
Title
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
Title
Percentage of patients that drop out of the study for adverse effects or intolerance
Time Frame
During the 12 weeks of follow-up
Title
Variations in levels of haemoglobin, neutrophil, and platelet count
Time Frame
at 4, 8, and 12 weeks with regard to baseline
Title
AIDS-defining events or death
Time Frame
During the 12 weeks of follow-up
Title
Changes in the CD4/CD8 cell count
Time Frame
At 4, 8, and 12 weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonaventura Clotet, MD, PhD
Organizational Affiliation
LLuita contra la Sida Foundation-HIV Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol, Badalona
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital General de Vic
City
Vic
State/Province
Barcelona
ZIP/Postal Code
08500
Country
Spain
Facility Name
Hospital de Donostia
City
San Sebastián
State/Province
Donostia
ZIP/Postal Code
20012
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Gregorio Marañón.
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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