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Completed

NCT Number: NCT00122616

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alpha-2a (Pegasys®)

Biological

Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly

Ribavirin

Drug

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

HIV antiretroviral therapy

Drug

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

Primary outcomes

  1. Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir).

    Time frame: Week 96

Secondary outcomes

  1. Distribution of the change of fibrosis Metavir score in each group

    Time frame: Week 96

  2. Distribution of fibrosis score from Chevallier classification

    Time frame: Week 96

  3. Plasmatic fibrosis markers dosages

    Time frame: Week 96

  4. Viral load quantification for HIV and HCV

    Time frame: Week 96

  5. Number and percentage of CD4/CD8 cell count throughout the study

    Time frame: Day 0 to week 96

  6. Number and percentage of patient had more thand 200 copies/ml throughout the study

    Time frame: Day 0 to week 96

  7. Occurrence of hepatic complication related to HCV

    Time frame: Day0 to week 96

  8. Survival throughout the study

    Time frame: Day 0 to week 96

  9. Quality of life questionnaire

    Time frame: Day 0 to week 96

  10. Fibrotest (plasmatic fibrosis marker)

    Time frame: Day 0, week 48 and week 96

  11. Histological improvement according to the total interferon dose received

    Time frame: Day 0 to week 96

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jul 22, 2005
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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