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

September 12, 2005
December 14, 2012
February 2002
December 2005   (final data collection date for primary outcome measure)
  • change in hemoglobin
  • change in absolute neutrophil count
Same as current
Complete list of historical versions of study NCT00194857 on ClinicalTrials.gov Archive Site
  • HCV RNA
  • depression
  • fatigue
Same as current
Not Provided
Not Provided
 
Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anemia
  • Neutropenia
  • Hepatitis C Virus
  • HIV Infections
Drug: erythropoietin, GCSF
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00194857
P03850-001, 0801-858
Not Provided
Not Provided
Weill Medical College of Cornell University
Schering-Plough
Principal Investigator: Andrew Talal, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP