Status:
COMPLETED
NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Hepatitis C
HIV
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HC...
Detailed Description
Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa \[PEG-IFN\] in combination with ribavirin \[RBV\]) frequently develop modera...
Eligibility Criteria
Inclusion
- HIV- infected patients confirmed by HIV-RNA level
- HCV- infected patients confirmed by PCR(polymerase chain reaction) or branched DNA (b-DNA)
- Scheduled to commence combination IFN/RBV therapy on Day 1
- Normal serum creatinine
- On stable antiretroviral regimen (for HIV) for at least 4 weeks
- Life expectancy \> 6 months
Exclusion
- Patients with history of any primary hematologic disease
- Anemia attributable to factors such as iron or folate deficiency, pre-treatment
- hemolysis or gastrointestinal bleeding
- Has suspected or confirmed significant hepatic disease from an etiology other than
- HCV (e.g. alcohol, HBV DNA, autoimmune disease etc)
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2003
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00315432
Start Date
September 1 2000
End Date
November 1 2003
Last Update
May 19 2011
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