| 5294 FACT SHEET |
| A Prospective, Phase III, Open-Label Study of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in HCV/HIV Coinfected Subjects
Boceprevir, Interferon, Ribavirin to Treat HCV/HIV Coinfected Subjects (BIRTH) (ACTG 5294)
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Purpose of This Trial:
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| To assess if adding Boceprevir (BOC) to the current standard-of-care regimen (Pegylated-interferon alfa 2b [PEG-IFN] + weight-based ribavirin [RBV]) will improve outcomes of hepatitis C virus (HCV) treatment in persons with HCV genotype 1 and HIV co-infection.
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You may be eligible if you are: |
- Men or women ≥ 18 years of age with HIV and hepatitis C
- Have hepatitis C genotype 1 infection
- Have a hepatitis C viral load greater than 10,000
- Have had a liver biopsy within 104 weeks prior to entry
- If on HIV meds, must be taking either raltegravir OR efavirenz AND have undetectable viral load
- If not on HIV meds, have HIV viral load less than 50,000
- Have a T-cell count greater than 200
- Not pregnant or breast feeding or planning pregnancy, or if you are a male, do not have a female partner who is pregnant
- Cannot be taking a HIV protease inhibitor
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| Medications While On Study: |
| Boceprevir, Pegylated-interferon alpha 2b, and Ribavirin (all provided by study)
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| Length of Study: |
| 72 weeks
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Schedule of Study Appointments: |
Screening, entry, and weeks 2,4,6,8,10,12,16, 20, 24, and every 4-8 weeks until week 72.
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Pharmacokinetic Substudy: |
You may be asked to take part in an optional sub-study (A5309s) that looks at the levels of BOC and raltegravir OR efavirenz in your blood. This will require additional blood draws over 12-24 hours on weeks 2 and 6 of the main study.
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| Reimbursement: |
- Clinical exams, study medications, and lab tests are provided at no cost.
- You will receive $20 per visit starting at Entry.
- You will receive $120 for each 12 hour sub-study visits, and another $30 if you have to come back the next day.
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Contact: |
The ACTU Screening Nurse at 206-744-3184.
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