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

NCT ID: NCT00122616

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2009-03-31

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.

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

Conditions

HIV Infections; Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy

Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy

Group Type: ACTIVE_COMPARATOR

Peginterferon alpha-2a (Pegasys®)

Intervention Type: BIOLOGICAL

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

Ribavirin

Intervention Type: 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

Intervention Type: 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

HIV antiretroviral therapy

Day0 to week 96: HIV antiretroviral therapy

Group Type: PLACEBO_COMPARATOR

HIV antiretroviral therapy

Intervention Type: 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

Interventions

Peginterferon alpha-2a (Pegasys®)

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

Intervention Type: BIOLOGICAL

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Marc Chapplain, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Pontchaillou Rennes

Eric Belissant, MD

Role: STUDY_CHAIR

CIC Hôpital Pontchaillou Rennes

Locations

Service de Maladies Infectieuses et de Réanimation Médicale

Rennes, , France

Countries

France

References

Chapplain JM, Bellissant E, Guyader D, Molina JM, Poizot-Martin I, Perre 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.

Reference Type: DERIVED

PMID: 23800784 (View on PubMed)

Other Identifiers

ANRSHC12 FIBROSTOP

Identifier Type: -

Identifier Source: org_study_id