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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.

NCT ID: NCT00002126

Last Updated: 2005-06-24

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Cytopenias

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Filgrastim

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Locations

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Univ of Alabama at Birmingham / AIDS Outpatient Clinic

Birmingham, Alabama, United States

Site Status

Maricopa County Med Ctr

Phoenix, Arizona, United States

Site Status

CARE Ctr / UCLA Med Ctr

Los Angeles, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Univ Hosp / Univ of Colorado Health Sci Ctr

Denver, Colorado, United States

Site Status

George Washington Univ Med Ctr

Washington D.C., District of Columbia, United States

Site Status

TheraFirst Med Ctrs Inc

Fort Lauderdale, Florida, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Univ of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

Tulane Univ Med School

New Orleans, Louisiana, United States

Site Status

New England Deaconess Hosp

Boston, Massachusetts, United States

Site Status

SUNY / Health Sciences Ctr at Stony Brook

Stony Brook, New York, United States

Site Status

Nalle Clinic

Charlotte, North Carolina, United States

Site Status

Univ Hosp of Cleveland / Case Western Reserve Univ

Cleveland, Ohio, United States

Site Status

Kaiser Permanente Med Ctr

Portland, Oregon, United States

Site Status

Univ TX San Antonio Health Science Ctr

San Antonio, Texas, United States

Site Status

Saint Paul's Hosp

Vancouver, British Columbia, Canada

Site Status

Sunnybrook Health Science Ctr

Toronto, Ontario, Canada

Site Status

Toronto Gen Hosp

Toronto, Ontario, Canada

Site Status

Wellesley Hosp

Toronto, Ontario, Canada

Site Status

Hotel - Dieu de Montreal

Montreal, Quebec, Canada

Site Status

Saint Michael's Hosp

Toronto, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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GCSF-930101

Identifier Type: -

Identifier Source: secondary_id

087A

Identifier Type: -

Identifier Source: org_study_id