NCT00194857

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

December 14, 2012

Conditions

AnemiaNeutropeniaHepatitis C VirusHIV Infections

Keywords

anemiadose reductionneutropeniahepatitis C virushuman immunodeficiency virus

Outcome Measures

Primary Outcomes (2)

  • change in hemoglobin

  • change in absolute neutrophil count

Secondary Outcomes (3)

  • HCV RNA

  • depression

  • fatigue

Interventions

erythropoietin, GCSFDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemoglobin \> 11
  • absolute neutrophil count \>1,200
  • naive to peg interferon and ribavirin

You may not qualify if:

  • Prior treatment for hepatitis C
  • Pregnant or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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.

    PMID: 21876446DERIVED

MeSH Terms

Conditions

AnemiaNeutropeniaHepatitis CHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Andrew Talal, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(1)