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

This study has been terminated.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194857
First received: September 12, 2005
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Anemia
Neutropenia
Hepatitis C Virus
HIV Infections
 Drug: erythropoietin, GCSF
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • change in hemoglobin
  • change in absolute neutrophil count

Secondary Outcome Measures:
  • HCV RNA
  • depression
  • fatigue

Study Start Date: February 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Weill Medical College of Cornell University

Additional 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
Study First Received: September 12, 2005
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Anemia
Hepatitis
Hepatitis A
Hepatitis C
Neutropenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Hematologic Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Agranulocytosis
Leukopenia
Leukocyte Disorders
Epoetin Alfa
Interferons
Ribavirin
Hematinics

ClinicalTrials.gov processed this record on May 23, 2013