search
Back to results

Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients (ROCO2)

Primary Purpose

HIV Infections, Hepatitis C, Chronic, Treatment Failure

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Peginterferon alfa2a
Ribavirin
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Hepatitis C, Chronic, HCV infection, HIV infection, Treatment Failure, PEG interferon, Interferons/therapeutic use, Interferon Alfa-2a/adverse effects, Ribavirin/therapeutic use, Ribavirin/adverse effects, Drug Therapy, Combination, Treatment Experienced, Treatment Naive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy Signed informed consent Exclusion Criteria: Chronic hepatitis B Alcohol consumption>40g/day Evidence of decompensated liver disease Hepatocellular carcinoma Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

Sites / Locations

  • Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD

Outcomes

Primary Outcome Measures

Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level

Secondary Outcome Measures

Proportion of patients with a virological response
Safety of treatment
Influence of anti-HCV treatment on CD4 count and HIV RNA
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

Full Information

First Posted
September 13, 2005
Last Updated
June 12, 2007
Sponsor
University Hospital, Bordeaux
Collaborators
Hoffmann-La Roche, Ministry of Health, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00221650
Brief Title
Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients
Acronym
ROCO2
Official Title
Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Hoffmann-La Roche, Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hepatitis C, Chronic, Treatment Failure
Keywords
Hepatitis C, Chronic, HCV infection, HIV infection, Treatment Failure, PEG interferon, Interferons/therapeutic use, Interferon Alfa-2a/adverse effects, Ribavirin/therapeutic use, Ribavirin/adverse effects, Drug Therapy, Combination, Treatment Experienced, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa2a
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Primary Outcome Measure Information:
Title
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level
Time Frame
24 weeks after the end of anti-HCV treatment
Secondary Outcome Measure Information:
Title
Proportion of patients with a virological response
Time Frame
at weeks 24 and 48
Title
Safety of treatment
Title
Influence of anti-HCV treatment on CD4 count and HIV RNA
Title
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy Signed informed consent Exclusion Criteria: Chronic hepatitis B Alcohol consumption>40g/day Evidence of decompensated liver disease Hepatocellular carcinoma Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Neau, MD-PhD
Organizational Affiliation
Hôpital Pellegrin, 33076 Bordeaux Cedex, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Genevieve Chene, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16879756
Citation
Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38. doi: 10.1186/1471-2288-6-38.
Results Reference
background

Learn more about this trial

Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients

We'll reach out to this number within 24 hrs