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Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin

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ClinicalTrials.gov Identifier: NCT00194857
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Anemia Neutropenia Hepatitis C Virus HIV Infections Drug: erythropoietin, GCSF Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2002
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia HIV/AIDS
Drug Information available for: Ribavirin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. change in hemoglobin
  2. change in absolute neutrophil count

Secondary Outcome Measures :
  1. HCV RNA
  2. depression
  3. fatigue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194857


Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Schering-Plough
Investigators
Principal Investigator: Andrew Talal, MD Weill Medical College of Cornell University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00194857     History of Changes
Other Study ID Numbers: P03850-001
0801-858
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Weill Medical College of Cornell University:
anemia
dose reduction
neutropenia
hepatitis C virus
human immunodeficiency virus

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Anemia
HIV Infections
Neutropenia
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hematologic Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Interferons
Ribavirin
Epoetin Alfa
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents