Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin
Primary Purpose
Anemia, Neutropenia, Hepatitis C Virus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
erythropoietin, GCSF
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia, dose reduction, neutropenia, hepatitis C virus, human immunodeficiency virus
Eligibility Criteria
Inclusion Criteria: hemoglobin > 11 absolute neutrophil count >1,200 naive to peg interferon and ribavirin Exclusion Criteria: Prior treatment for hepatitis C Pregnant or nursing
Sites / Locations
- Weill Medical College of Cornell University
Outcomes
Primary Outcome Measures
change in hemoglobin
change in absolute neutrophil count
Secondary Outcome Measures
HCV RNA
depression
fatigue
Full Information
NCT ID
NCT00194857
First Posted
September 12, 2005
Last Updated
December 14, 2012
Sponsor
Weill Medical College of Cornell University
Collaborators
Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00194857
Brief Title
Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin
Official Title
A Randomized Clinical Trial Comparing Two Management Strategies for Treatment of Neutropenia and Anemia Associated With Pegylated Interferon Plus Ribavirin Treatment of Compensated Chronic Hepatitis C in Adult Subjects Infected With HIV.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Schering-Plough
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Neutropenia, Hepatitis C Virus, HIV Infections
Keywords
anemia, dose reduction, neutropenia, hepatitis C virus, human immunodeficiency virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
erythropoietin, GCSF
Primary Outcome Measure Information:
Title
change in hemoglobin
Title
change in absolute neutrophil count
Secondary Outcome Measure Information:
Title
HCV RNA
Title
depression
Title
fatigue
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hemoglobin > 11
absolute neutrophil count >1,200
naive to peg interferon and ribavirin
Exclusion Criteria:
Prior treatment for hepatitis C
Pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Talal, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21876446
Citation
Talal AH, Liu RC, Zeremski M, Dimova R, Dove L, Pearce D, Hassanein T, Doonquah L, Aboulafia D, Rodriguez J, Bonilla H, Galpin J, Aberg JA, Johnston B, Glesby MJ, Jacobson IM. Randomized trial comparing dose reduction and growth factor supplementation for management of hematological side effects in HIV/hepatitis C virus patients receiving pegylated-interferon and ribavirin. J Acquir Immune Defic Syndr. 2011 Nov 1;58(3):261-8. doi: 10.1097/QAI.0b013e3182324af9.
Results Reference
derived
Learn more about this trial
Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin
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