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Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122616
First received: July 19, 2005
Last updated: February 21, 2012
Last verified: February 2012

July 19, 2005
February 21, 2012
November 2003
March 2009   (final data collection date for primary outcome measure)
Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir). [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
percentage of patient who experienced one point decreases of their fibrosis histological score (Metavir).
Complete list of historical versions of study NCT00122616 on ClinicalTrials.gov Archive Site
  • Distribution of the change of fibrosis Metavir score in each group [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Distribution of fibrosis score from Chevallier classification [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Plasmatic fibrosis markers dosages [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Viral load quantification for HIV and HCV [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Number and percentage of CD4/CD8 cell count throughout the study [ Time Frame: Day 0 to week 96 ] [ Designated as safety issue: No ]
  • Number and percentage of patient had more thand 200 copies/ml throughout the study [ Time Frame: Day 0 to week 96 ] [ Designated as safety issue: No ]
  • Occurrence of hepatic complication related to HCV [ Time Frame: Day0 to week 96 ] [ Designated as safety issue: No ]
  • Survival throughout the study [ Time Frame: Day 0 to week 96 ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: Day 0 to week 96 ] [ Designated as safety issue: No ]
  • Fibrotest (plasmatic fibrosis marker) [ Time Frame: Day 0, week 48 and week 96 ] [ Designated as safety issue: No ]
  • Histological improvement according to the total interferon dose received [ Time Frame: Day 0 to week 96 ] [ Designated as safety issue: No ]
  • Distribution of the change of fibrosis Metavir score in each group at W 96
  • Distribution of fibrosis score from Chevallier classication atW 96
  • Plasmatic fibrosis markers dosages at W 96
  • Viral load quantification for HIV and HCV at W 96
  • Number and percentage of CD4 cell count throughout the study
  • Number and percentage of patient below 200 copies/ml throughout the study
  • Occurrence of hepatic complication related to HCV
  • Survival throughout the study
  • Quality of life questionnaire
  • Fibrotest (plasmatic fibrosis marker)at W 96
  • Histological improvement according to the total interferon dose received
Not Provided
Not Provided
 
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and C Hepatitis Who Failed to Active Treatment for HCV. ANRSHC12 Fibrostop

The aim of this study is to prove the efficacy of peginterferon in HIV infected patients with liver disease caused by hepatitis C virus (HCV) when the treatment to eradicate the virus failed. This scientific proof needs a comparative study to be done including two groups of patients randomly allocated: one with the treatment (peginterferon) and the other without any treatment against HCV with a duration of 2 years. To conclude, two liver biopsies are needed; one before the study and a second 2 years after.

C hepatitis in HIV infected patient becomes a major issue although the survival of patients, has improved in the last decades regarding to the advent of HAART, the mortality related to liver disease has increased in this population. Sustained virological response for HCV can be obtained with peg-interferon and ribavirin treatment but more or less 50% of patients experienced failure to this treatment and liver fibrosis due to HCV infection progress and may lead to cirrhosis and hepato-carcinoma. To demonstrate the efficacy of peginterferon therapy to reduce the liver damage causes by HCV infection, a randomised controlled study is needed comparing one group of patient treated by peginterferon and one group without any treatment against HCV infection. In order to show 30% difference between the two groups in reducing one point of fibrosis score (METAVIR scale), 150 patients are needed. The duration of the study is 96 weeks

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C, Chronic
  • Biological: Peginterferon alpha-2a (Pegasys®)
    Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly
  • Drug: Ribavirin
    Ribavirin: tablet oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over 75 kg, once daily
  • Drug: HIV antiretroviral therapy
    All antiretroviral drugs are allowed, their choice being left to the discretion of the investigator. Particular attention will be carried to the patients with antiretroviral susceptible to cause a cumulative toxicity with anti-VHC drugs
  • Active Comparator: Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
    Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
    Interventions:
    • Biological: Peginterferon alpha-2a (Pegasys®)
    • Drug: Ribavirin
    • Drug: HIV antiretroviral therapy
  • Placebo Comparator: HIV antiretroviral therapy
    Day0 to week 96: HIV antiretroviral therapy
    Intervention: Drug: HIV antiretroviral therapy
Chapplain JM, Bellissant E, Guyader D, Molina JM, Poizot-Martin I, Perré P, Pialoux G, Turlin B, Mouchel C, Renault A, Michelet C; ANRS HC-12 Study Group. The effects of a maintenance therapy with peg-interferon alpha-2a on liver fibrosis in HIV/HCV co-infected patients: a randomized controlled trial. J Infect. 2013 Oct;67(4):313-21. doi: 10.1016/j.jinf.2013.05.007. Epub 2013 Jun 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection (Western Blot +)
  • C hepatitis (RNA viral hepatitis C [VHC] +)
  • Chronic active C hepatitis on liver histological score METAVIR (A over or equal to 1 and F over or equal to 2) on biopsy performed at least 18 months before the expected date of inclusion
  • Previous treatment for C hepatitis for at least 3 months including peg-interferon and ribavirin or peg-interferon alone if counterindication for ribavirin occurred
  • Failure to eradicate C hepatitis virus after well conducted treatment
  • The liver biopsy should have been realised at least 18 months before inclusion :

Either before treatment for C hepatitis in patients treated at most 7 months Or at least 6 months after anti HCV treatment in patient treated for more than 7 months (wash out period)

  • Regular follow up in an outpatient clinic for HIV
  • Unchanged antiretroviral treatment the last 3 months before inclusion
  • Inform consent

Exclusion Criteria:

  • History of transplantation or clinical hepatic failure
  • Opportunistic infection in the past three months before inclusion
  • Any hepatic disease not related to HCV (B hepatitis, hemochromatosis, Wilson disease)
  • Diabetes mellitus
  • Immunocompromised treatment
  • Active intravenous drug addiction
  • Alcohol consumption of more than 50 g per day
  • Counterindication for the use of interferon
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122616
ANRSHC12 FIBROSTOP
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Principal Investigator: Jean Marc Chapplain, MD Hopital Pontchaillou Rennes
Study Chair: Eric Belissant, MD CIC Hôpital Pontchaillou Rennes
French National Agency for Research on AIDS and Viral Hepatitis
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP