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| ID | Type | Description | Link |
|---|---|---|---|
| 2000-023 |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
| Ministry of Health, France | OTHER_GOV |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa2a | Drug | |||
| Ribavirin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level | 24 weeks after the end of anti-HCV treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a virological response | at weeks 24 and 48 | |
| Safety of treatment | ||
| Influence of anti-HCV treatment on CD4 count and HIV RNA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Neau, MD-PhD | Hôpital Pellegrin, 33076 Bordeaux Cedex, France | Principal Investigator |
| Genevieve Chene, Pr | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16879756 | Background | 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. doi: 10.1186/1471-2288-6-38. | |
| 15820563 | Result | Seydi M, Morlat P, Bonnet F, Rambeloarisoa J, Bernard N, Lacoste D, Bonarek M, Trimoulet P, Ramanampamonjy R, Lafon ME, Drame M, Beylot J. [Efficacy and safety of pegylated-interferon plus ribavirin in HIV-infected patients co-infected with hepatitis C virus in clinical practice: a 32 cases observational follow-up]. Rev Med Interne. 2005 Apr;26(4):280-7. doi: 10.1016/j.revmed.2004.11.022. French. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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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| Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment |
| 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 |
| 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 |