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

Weill Cornell Medicine (WCM)

Status and phase: Terminated; Phase 4

Conditions: Anemia; Neutropenia; HIV Infections; Hepatitis C Virus

Treatments: Drug: erythropoietin, GCSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00194857

0801-858

P03850-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)