A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.

June 23, 2005 updated by: Amgen

A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection

To determine, in HIV-infected patients, the efficacy of filgrastim ( recombinant-methionyl human granulocyte-colony stimulating factor; G-CSF ) in preventing grade 4 neutropenia, i.e., absolute neutrophil count (ANC) < 500 cells/mm3.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive subcutaneous G-CSF at one of two different doses or no G-CSF (observation) for 24 weeks. Patients who experience ANC < 500 cells/mm3 on two consecutive occasions at least 24 hours apart prior to completing the 24-week study period will be considered to have reached the primary study endpoint; those in the observation group who reach the primary endpoint prior to week 24 may begin receiving G-CSF for the remainder of the study period. After 24 weeks, patients may continue G-CSF on a compassionate basis at the investigator's discretion.

Study Type

Interventional

Enrollment

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Saint Michael's Hosp
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hosp
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Ctr
      • Toronto, Ontario, Canada
        • Toronto Gen Hosp
      • Toronto, Ontario, Canada
        • Wellesley Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Hotel - Dieu de Montreal
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham / AIDS Outpatient Clinic
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa County Med Ctr
    • California
      • Los Angeles, California, United States, 90095
        • CARE Ctr / UCLA Med Ctr
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ Hosp / Univ of Colorado Health Sci Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Kansas
      • Wichita, Kansas, United States, 672143124
        • Univ of Kansas School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ Med School
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • New England Deaconess Hosp
    • New York
      • Stony Brook, New York, United States, 11794
        • SUNY / Health Sciences Ctr at Stony Brook
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Med Ctr
    • Texas
      • San Antonio, Texas, United States, 78284
        • Univ TX San Antonio Health Science Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral agents (e.g., AZT, ganciclovir, ddI, ddC), trimethoprim-sulfamethoxazole (Bactrim), interferon, and amphotericin B ONLY IF patient is on the same dose for at least 14 days prior to study entry (patients may not start or stop these agents within 14 days prior to study entry).

Patients must have:

  • Documented HIV infection OR history of AIDS.
  • CD4 count < 200 cells/mm3.
  • ANC (segmental neutrophils plus bands) >= 750 and < 1000 cells/mm3 within 7 days prior to study entry.
  • Life expectancy of at least 6 months.

NOTE:

  • Stable Kaposi's sarcoma is permitted provided patient does not require myelosuppressive therapy (other than interferon) within 4 weeks prior to study entry.

Prior Medication:

Allowed:

  • Prior antiretroviral agents (e.g., AZT, ganciclovir, ddI, ddC), trimethoprim-sulfamethoxazole (Bactrim), interferon, and amphotericin B.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malignancy other than Kaposi's sarcoma and localized basal or squamous cell carcinoma.
  • Psychiatric, addictive, or other disorder that compromises ability to give informed consent.
  • Known hypersensitivity to E. coli-derived products.

Prior Medication:

Excluded:

  • G-CSF, other hematopoietic growth factors (except for erythropoietin), or investigational agents within 14 days prior to study entry.

Substance abuse that would compromise compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 087A
  • GCSF-930101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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