search
Back to results

ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV (ETOC)

Primary Purpose

Hepatitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Peg-interféron alpha 2a + ribavirin
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis focused on measuring HCV Genotype 1, 4, Virological response, Ribavirin, PegPegIFN- alpha 2a, Viral Hepatitis (HCV)

Eligibility Criteria

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

Inclusion Criteria:

  • Age over 18 years
  • Weight 85 kg below the pre-inclusion visit.
  • Documented HIV infection (HIV positive)
  • HCV infection documented by a positive PCR
  • HCV Genotype 1 or 4
  • Compensated liver disease (Child-Pugh below/equal to 6)
  • Lymphocytes CD4 above 200/mm3
  • Patient not answering a treatment for hepatitis C.
  • Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)

Exclusion Criteria:

  • Co-infection with HBV (HBsAg positive)
  • Neutropenia below 1000/mm3
  • Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3.
  • Hemoglobin below 11 g / dL (men and women)
  • Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell
  • Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).

Sites / Locations

  • Hôpital Tenon Service des Maladies Infectieuses

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

PegIFN- alpha 2a + RBV

Arm Description

Outcomes

Primary Outcome Measures

Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.

Secondary Outcome Measures

Analyze rapid virological response (W4) and early (W12).

Full Information

First Posted
April 28, 2009
Last Updated
March 28, 2013
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Roche Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00901524
Brief Title
ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV
Acronym
ETOC
Official Title
ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.
Detailed Description
In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments. However, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis
Keywords
HCV Genotype 1, 4, Virological response, Ribavirin, PegPegIFN- alpha 2a, Viral Hepatitis (HCV)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PegIFN- alpha 2a + RBV
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Peg-interféron alpha 2a + ribavirin
Intervention Description
Pilot study, multicenter, open label
Primary Outcome Measure Information:
Title
Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.
Time Frame
W72 or W96 (depending of the end of treatment)
Secondary Outcome Measure Information:
Title
Analyze rapid virological response (W4) and early (W12).
Time Frame
W4 and W12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years Weight 85 kg below the pre-inclusion visit. Documented HIV infection (HIV positive) HCV infection documented by a positive PCR HCV Genotype 1 or 4 Compensated liver disease (Child-Pugh below/equal to 6) Lymphocytes CD4 above 200/mm3 Patient not answering a treatment for hepatitis C. Patient not covered by dual by Peg-IFN + riba for at least three months (wash out) Exclusion Criteria: Co-infection with HBV (HBsAg positive) Neutropenia below 1000/mm3 Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3. Hemoglobin below 11 g / dL (men and women) Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe BONNARD, MD
Organizational Affiliation
Hopital Tenon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Tenon Service des Maladies Infectieuses
City
Paris
ZIP/Postal Code
75970
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24905490
Citation
Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hezode C, Rosa I, Renard P, Mohamed MK, Bonnard P, Izopet J, Mallet V, Pol S, Albert ML, Fontanet A. Apolipoprotein H expression is associated with IL28B genotype and viral clearance in hepatitis C virus infection. J Hepatol. 2014 Oct;61(4):770-6. doi: 10.1016/j.jhep.2014.05.040. Epub 2014 Jun 4.
Results Reference
derived
Links:
URL
http://www.anrs.fr
Description
French National Agency for Research on AIDS and Viral Hepatitis website

Learn more about this trial

ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV

We'll reach out to this number within 24 hrs