Efficacy of Pegylated Interferon on Liver Fibrosis in co-Infected Patient With HIV and Hepatitis C - Full Text View

Sponsors and Collaborators:	French National Agency for Research on AIDS and Viral Hepatitis Hoffmann-La Roche
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00122616

Purpose

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	Intervention	Phase
HIV Infections Hepatitis C, Chronic	Drug: peginterferon alfa 2-a	Phase III

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Peginterferon Alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Distribution of the change of fibrosis Metavir score in each group at Week (W) 96
Distribution of fibrosis score from Chevallier classification at W 96
Plasmatic fibrosis markers dosages at W 96
Viral load quantification for HIV and HCV at W 96
Number and percentage of CD4 cell count throughout the study
Number and percentage of patient below 200 copies/ml throughout the study
Occurrence of hepatic complication related to HCV
Survival throughout the study
Quality of life questionnaire
Fibrotest (plasmatic fibrosis marker) at W 96
Histological improvement according to the total interferon dose received

Estimated Enrollment:	150
Study Start Date:	July 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	ANRSHC12 FIBROSTOP
Study First Received:	July 19, 2005
Last Updated:	January 11, 2007
ClinicalTrials.gov Identifier:	NCT00122616
Health Authority:	France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:

Interferon-alpha
Sexually Transmitted Diseases, Viral
Liver Diseases
Hepatic fibrosis
Hepatitis, Chronic
Fibrosis
Interferons
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Liver Cirrhosis
Immunologic Deficiency Syndromes

Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Flaviviridae Infections
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Infection
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009