Clinical trial NCT00122616: Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Hepatitis C, Chronic
Keywords: HIV infections
peginterferon alfa-2a
Treatment Failure
Hepatitis C, Chronic
Treatment Experienced
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Hoffmann-La Roche
First posted: 2005-07-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir).
timeFrame: Week 96
Secondary outcomes:
measure: Distribution of the change of fibrosis Metavir score in each group
timeFrame: Week 96
measure: Distribution of fibrosis score from Chevallier classification
timeFrame: Week 96
measure: Plasmatic fibrosis markers dosages
timeFrame: Week 96
measure: Viral load quantification for HIV and HCV
timeFrame: Week 96
measure: Number and percentage of CD4/CD8 cell count throughout the study
timeFrame: Day 0 to week 96
measure: Number and percentage of patient had more thand 200 copies/ml throughout the study
timeFrame: Day 0 to week 96
measure: Occurrence of hepatic complication related to HCV
timeFrame: Day0 to week 96
measure: Survival throughout the study
timeFrame: Day 0 to week 96
measure: Quality of life questionnaire
timeFrame: Day 0 to week 96
measure: Fibrotest (plasmatic fibrosis marker)
timeFrame: Day 0, week 48 and week 96
measure: Histological improvement according to the total interferon dose received
timeFrame: Day 0 to week 96
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de Maladies Infectieuses et de Réanimation Médicale
Study officials:
affiliation: Hopital Pontchaillou Rennes
name: Jean Marc Chapplain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Hôpital Pontchaillou Rennes
name: Eric Belissant, MD
role: STUDY_CHAIR
References:
citation: 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.