Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients - Full Text View

Sponsors and Collaborators:	University Hospital, Bordeaux Hoffmann-La Roche Ministry of Health, France
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00221650

Purpose

Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin.

The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.

Condition	Intervention	Phase
HIV Infections Hepatitis C, Chronic Treatment Failure	Drug: Peginterferon alfa2a Drug: Ribavirin	Phase II

MedlinePlus related topics: AIDS Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2a Peginterferon Alfa-2a Interferon alfa-n1 Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level [ Time Frame: 24 weeks after the end of anti-HCV treatment ]

Secondary Outcome Measures:

Proportion of patients with a virological response [ Time Frame: at weeks 24 and 48 ]
Safety of treatment
Influence of anti-HCV treatment on CD4 count and HIV RNA
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment

Enrollment:	17
Study Start Date:	April 2002
Study Completion Date:	June 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level
HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy
Signed informed consent

Exclusion Criteria:

Chronic hepatitis B
Alcohol consumption>40g/day
Evidence of decompensated liver disease
Hepatocellular carcinoma
Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221650

Locations

France
Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD
Bordeaux, France, 33076

Sponsors and Collaborators

University Hospital, Bordeaux

Hoffmann-La Roche

Ministry of Health, France

Investigators

Principal Investigator:	Didier Neau, MD-PhD	Hôpital Pellegrin, 33076 Bordeaux Cedex, France
Study Chair:	Genevieve Chene, Pr	University Hospital, Bordeaux

More Information

Publications:

Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38.

Study ID Numbers:	9232-01, 2000-023
Study First Received:	September 13, 2005
Last Updated:	June 12, 2007
ClinicalTrials.gov Identifier:	NCT00221650 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Hepatitis C, Chronic
HCV infection
HIV infection
Treatment Failure
PEG interferon
Interferons/therapeutic use

Interferon Alfa-2a/adverse effects
Ribavirin/therapeutic use
Ribavirin/adverse effects
Drug Therapy, Combination
Treatment Experienced
Treatment Naive

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Sexually Transmitted Diseases, Viral
Liver Diseases
Immunologic Factors
Hepatitis, Chronic
Interferons
Ribavirin
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents

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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Liver Diseases
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Hepatitis, Chronic
Flaviviridae Infections
Antineoplastic Agents
Physiological Effects of Drugs
Ribavirin
Hepatitis, Viral, Human
Infection
Therapeutic Uses

Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Retroviridae Infections
Interferon-alpha
RNA Virus Infections
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Interferons
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases

ClinicalTrials.gov processed this record on May 06, 2009