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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00470210 |
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Date of registration:
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04/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Peginterferon Alfa-2a, Ribavirin and Epoetin ß in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens
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Scientific title:
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Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin ß (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00470210 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Bonaventura Clotet, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Germans Trias i Pujol Hospital |
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Name:
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Cristina Tural, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Germans Trias i Pujol Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- HIV-infected patients coinfected with HCV genotypes 1 or 4
- Persistent transaminase elevation
- Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage
of 800-1200 mg/d.
Exclusion Criteria:
- Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
- Patients with Child-Pugh B or C cirrhosis
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Hepatitis C
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Intervention(s)
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Drug: Epoetin ß (450 UI/kg/week)
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Drug: Ribavirin (Copegus®) 1600 mg/day
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Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
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Primary Outcome(s)
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Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
[Time Frame: 24 weeks after finishing treatment]
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Secondary Outcome(s)
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Changes in serum HCV-RNA titers
[Time Frame: between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment]
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Percentage of patients with serum HCV-RNA loads of < 50 IU/mL
[Time Frame: at weeks 4, 8, 12, 24, and 48]
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Secondary ID(s)
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MORE
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2006-005554-74
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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