Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin
- Conditions
- AnemiaNeutropeniaHepatitis C VirusHIV Infections
- Registration Number
- NCT00194857
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
This study is designed to test two separate strategies for treatment of anemia (low hemoglobin) and neutropenia (low white blood cells) in HIV/HCV coinfected patients who are being treated with pegylated interferon and ribavirin.
- Detailed Description
This is a multi-center, randomized, open-labeled trial in subjects co-infected with hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1) who are naïve to anti-HCV therapy. Subjects will receive PEG interferon alfa-2b (PEG-IFN) 1.5 mcg/kg/week administered once weekly plus ribavirin (RBV) 13 + 2 mg/kg/day. The goal of this study is to evaluate two different treatment options for anemia and neutropenia associated with the initiation of pegylated interferon and ribavirin. This will result in completion of therapy, and possibly a better viral sustained response.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- hemoglobin > 11
- absolute neutrophil count >1,200
- naive to peg interferon and ribavirin
- Prior treatment for hepatitis C
- Pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in hemoglobin change in absolute neutrophil count
- Secondary Outcome Measures
Name Time Method HCV RNA depression fatigue
Trial Locations
- Locations (1)
Weill Medical College of Cornell University
🇺🇸New York, New York, United States