Efficacy of Pegylated Interferon on Liver Fibrosis in Co-infected Patient With HIV and Hepatitis C
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ClinicalTrials.gov Identifier: NCT00122616 |
Recruitment Status
:
Completed
First Posted
: July 22, 2005
Last Update Posted
: February 22, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Hepatitis C, Chronic | Biological: Peginterferon alpha-2a (Pegasys®) Drug: Ribavirin Drug: HIV antiretroviral therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | November 2003 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy
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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
Drug: 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
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Placebo Comparator: HIV antiretroviral therapy
Day0 to week 96: HIV antiretroviral therapy
|
Drug: 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
|
- Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir). [ Time Frame: Week 96 ]
- Distribution of the change of fibrosis Metavir score in each group [ Time Frame: Week 96 ]
- Distribution of fibrosis score from Chevallier classification [ Time Frame: Week 96 ]
- Plasmatic fibrosis markers dosages [ Time Frame: Week 96 ]
- Viral load quantification for HIV and HCV [ Time Frame: Week 96 ]
- Number and percentage of CD4/CD8 cell count throughout the study [ Time Frame: Day 0 to week 96 ]
- Number and percentage of patient had more thand 200 copies/ml throughout the study [ Time Frame: Day 0 to week 96 ]
- Occurrence of hepatic complication related to HCV [ Time Frame: Day0 to week 96 ]
- Survival throughout the study [ Time Frame: Day 0 to week 96 ]
- Quality of life questionnaire [ Time Frame: Day 0 to week 96 ]
- Fibrotest (plasmatic fibrosis marker) [ Time Frame: Day 0, week 48 and week 96 ]
- Histological improvement according to the total interferon dose received [ Time Frame: Day 0 to week 96 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122616
France | |
Service de Maladies Infectieuses et de Réanimation Médicale | |
Rennes, France, 35033 |
Principal Investigator: | Jean Marc Chapplain, MD | Hopital Pontchaillou Rennes | |
Study Chair: | Eric Belissant, MD | CIC Hôpital Pontchaillou Rennes |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00122616 History of Changes |
Other Study ID Numbers: |
ANRSHC12 FIBROSTOP |
First Posted: | July 22, 2005 Key Record Dates |
Last Update Posted: | February 22, 2012 |
Last Verified: | February 2012 |
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 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C HIV Infections Hepatitis C, Chronic Liver Cirrhosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections |
Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Hepatitis, Chronic Interferons Ribavirin Peginterferon alfa-2a Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |