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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00194857
• Other study ID #: P03850-001
• Secondary ID: 0801-858
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 14, 2012
• Start date: February 2002
• Est. completion date: December 2005

Study information

• Verified date: December 2012
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Hepatitis
• Hepatitis C
• Hepatitis C Virus
• HIV Infections
• Neutropenia

Intervention

Drug:
• erythropoietin, GCSF

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hemoglobin
Primary	change in absolute neutrophil count
Secondary	HCV RNA
Secondary	depression
Secondary	fatigue