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

Sponsors and Collaborators:	Weill Medical College of Cornell University Schering-Plough
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00194857

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 IV

MedlinePlus related topics: AIDS Anemia Hepatitis Hepatitis C

Drug Information available for: Epoetin alfa Erythropoietin Granulocyte colony-stimulating factor Ribavirin Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
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.

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

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

Study ID Numbers:	P03850-001, 0801-858
Study First Received:	September 12, 2005
Last Updated:	October 21, 2005
ClinicalTrials.gov Identifier:	NCT00194857
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

Study placed in the following topic categories:

Epoetin Alfa
Liver Diseases
Sexually Transmitted Diseases, Viral
Hepatitis, Chronic
Hematologic Diseases
Interferons
Ribavirin
Acquired Immunodeficiency Syndrome
Agranulocytosis
Anemia
Hepatitis, Viral, Human
Leukocyte Disorders

Granulocytopenia
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Neutropenia
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Hepatitis C
Leukopenia
Hepatitis C, Chronic
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Flaviviridae Infections

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009