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.

Completed · Phase 2

Conditions studied: HIV Infections, Cytopenias

In brief

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.

Key facts

Study ID

NCT00002126

Run by

Amgen

People needed

250

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Univ of Alabama at Birmingham / AIDS Outpatient Clinic — Birmingham, Alabama, United States
• Maricopa County Med Ctr — Phoenix, Arizona, United States
• CARE Ctr / UCLA Med Ctr — Los Angeles, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Univ Hosp / Univ of Colorado Health Sci Ctr — Denver, Colorado, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• TheraFirst Med Ctrs Inc — Fort Lauderdale, Florida, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Tulane Univ Med School — New Orleans, Louisiana, United States
• New England Deaconess Hosp — Boston, Massachusetts, United States
• SUNY / Health Sciences Ctr at Stony Brook — Stony Brook, New York, United States
• Nalle Clinic — Charlotte, North Carolina, United States
• Univ Hosp of Cleveland / Case Western Reserve Univ — Cleveland, Ohio, United States
• Kaiser Permanente Med Ctr — Portland, Oregon, United States
• Univ TX San Antonio Health Science Ctr — San Antonio, Texas, 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

Full record on ClinicalTrials.gov

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