Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-Infected Patients (ROCO2)
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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 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
- 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 ]
- 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 |
![](https://webarchive.library.unt.edu/web/20130305095848im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130305095848im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
France | |
Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD | |
Bordeaux, France, 33076 |
Principal Investigator: | Didier Neau, MD-PhD | Hôpital Pellegrin, 33076 Bordeaux Cedex, France |
Study Chair: | Genevieve Chene, Pr | University Hospital, Bordeaux |
![](https://webarchive.library.unt.edu/web/20130305095848im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
ClinicalTrials.gov Identifier: | NCT00221650 History of Changes |
Other Study ID Numbers: | 9232-01, 2000-023 |
Study First Received: | September 13, 2005 |
Last Updated: | June 12, 2007 |
Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a Interferons Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2013