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The purpose of the study is to explore the treatment of patients with acute hepatitis C infection (infection acquired within the last 6 months) who are also infected with human immunodeficiency virus (HIV).
In this study, we will compare two treatment options for hepatitis C in patients who also have HIV infection, to see if there are any differences in the numbers of patients treated who successfully got rid of the hepatitis C virus when the treatment was complete. We will also compare how well the two treatment options are tolerated by the patients taking them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribavirin | Other | ARM 1: PEG-IFN and weight-based ribavirin (RBV) |
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| Telaprevir | Other | ARM 2: PEG-IFN and weight-based RBV plus telaprevir (TPV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | 24 weeks in those achieving RVR (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy | 24 weeks |
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Inclusion Criteria:
1. Is male or female aged 18 years or above 2. Has signed the Informed Consent Form voluntarily 3. Documented current acute hepatitis C genotype 1 infection with detectable HCV-RNA (PCR-assay) with an estimated duration less than 24 weeks as defined below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Nelson, Dr | St Stephens AIDS Trust, St Stephens Centre, Chelsea and Westminster Hospital, 369 Fulham Road, London, SW10 9EL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Stephens AIDS Trust | London | SW10 9TH | United Kingdom |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Telaprevir | Drug | 12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA >25 but <1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA >1000 iU/mL at week 4). |
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