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

NCT ID: NCT00194857

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anemia Neutropenia Hepatitis C Virus HIV Infections

Keywords

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anemia dose reduction neutropenia hepatitis C virus human immunodeficiency virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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erythropoietin, GCSF

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Principal Investigators

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Andrew Talal, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Medical College of Cornell University

New York, New York, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/QAI.0b013e3182324af9.

Reference Type DERIVED
PMID: 21876446 (View on PubMed)

Other Identifiers

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0801-858

Identifier Type: -

Identifier Source: secondary_id

P03850-001

Identifier Type: -

Identifier Source: org_study_id