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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy | Active Comparator | Day0 to week 96:Peginterféron alpha-2a + Ribavirin+ HIV antiretroviral therapy |
|
| HIV antiretroviral therapy | Placebo Comparator | Day0 to week 96: HIV antiretroviral therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alpha-2a (Pegasys®) | Biological | Peg-Interferon Alpha2a by subcutaneous injection, 180µg, once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who experienced one point decreases of their fibrosis histological score (Metavir). | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the change of fibrosis Metavir score in each group | Week 96 | |
| Distribution of fibrosis score from Chevallier classification | Week 96 | |
| Plasmatic fibrosis markers dosages |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Marc Chapplain, MD | Hopital Pontchaillou Rennes | Principal Investigator |
| Eric Belissant, MD | CIC HĂ´pital Pontchaillou Rennes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Maladies Infectieuses et de Réanimation Médicale | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23800784 | Derived | 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. |
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| Ribavirin | Drug | 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 |
|
| HIV antiretroviral therapy | Drug | 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 |
|
| HIV antiretroviral therapy | Drug | 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 |
|
| Week 96 |
| Viral load quantification for HIV and HCV | Week 96 |
| Number and percentage of CD4/CD8 cell count throughout the study | Day 0 to week 96 |
| Number and percentage of patient had more thand 200 copies/ml throughout the study | Day 0 to week 96 |
| Occurrence of hepatic complication related to HCV | Day0 to week 96 |
| Survival throughout the study | Day 0 to week 96 |
| Quality of life questionnaire | Day 0 to week 96 |
| Fibrotest (plasmatic fibrosis marker) | Day 0, week 48 and week 96 |
| Histological improvement according to the total interferon dose received | Day 0 to week 96 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006526 | Hepatitis C |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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