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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122616
• Other study ID #: ANRSHC12 FIBROSTOP
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2005
• Last updated: February 21, 2012
• Start date: November 2003
• Est. completion date: March 2009

Study information

• Verified date: February 2012
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• HIV Infections

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
France	Service de Maladies Infectieuses et de Réanimation Médicale	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir).		Week 96	No
Secondary	Distribution of the change of fibrosis Metavir score in each group		Week 96	No
Secondary	Distribution of fibrosis score from Chevallier classification		Week 96	No
Secondary	Plasmatic fibrosis markers dosages		Week 96	No
Secondary	Viral load quantification for HIV and HCV		Week 96	No
Secondary	Number and percentage of CD4/CD8 cell count throughout the study		Day 0 to week 96	No
Secondary	Number and percentage of patient had more thand 200 copies/ml throughout the study		Day 0 to week 96	No
Secondary	Occurrence of hepatic complication related to HCV		Day0 to week 96	No
Secondary	Survival throughout the study		Day 0 to week 96	No
Secondary	Quality of life questionnaire		Day 0 to week 96	No
Secondary	Fibrotest (plasmatic fibrosis marker)		Day 0, week 48 and week 96	No
Secondary	Histological improvement according to the total interferon dose received		Day 0 to week 96	No