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

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ClinicalTrials.gov Identifier: NCT00122616
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : February 22, 2012
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis C, Chronic Biological: Peginterferon alpha-2a (Pegasys®) Drug: Ribavirin Drug: HIV antiretroviral therapy Phase 3

Detailed Description:
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
 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
Placebo Comparator: HIV antiretroviral therapy
Day0 to week 96: HIV antiretroviral therapy
 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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir). [ Time Frame: Week 96 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122616


Locations
France
Service de Maladies Infectieuses et de Réanimation Médicale
Rennes, France, 35033
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Hoffmann-La Roche
Investigators
Principal Investigator: Jean Marc Chapplain, MD Hopital Pontchaillou Rennes
Study Chair: Eric Belissant, MD CIC Hôpital Pontchaillou Rennes
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00122616     History of Changes
Other Study ID Numbers: ANRSHC12 FIBROSTOP
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections
peginterferon alfa-2a
Treatment Failure
Hepatitis C, Chronic
Treatment Experienced

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
 Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action