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.
2 other identifiers
interventional
250
2 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (22)
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294, United States
Maricopa County Med Ctr
Phoenix, Arizona, 85008, United States
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124, United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699, United States
New England Deaconess Hosp
Boston, Massachusetts, 02215, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 11794, United States
Nalle Clinic
Charlotte, North Carolina, 28207, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Kaiser Permanente Med Ctr
Portland, Oregon, 97227, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Wellesley Hosp
Toronto, Ontario, Canada
Hotel - Dieu de Montreal
Montreal, Quebec, Canada
Saint Michael's Hosp
Toronto, Canada