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.
HIV Infections, Cytopenias
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Neutropenia, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome
Eligibility Criteria
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.
Sites / Locations
- Univ of Alabama at Birmingham / AIDS Outpatient Clinic
- Maricopa County Med Ctr
- CARE Ctr / UCLA Med Ctr
- UCSF - San Francisco Gen Hosp
- Univ Hosp / Univ of Colorado Health Sci Ctr
- George Washington Univ Med Ctr
- TheraFirst Med Ctrs Inc
- Rush Presbyterian - Saint Luke's Med Ctr
- Univ of Kansas School of Medicine
- Tulane Univ Med School
- New England Deaconess Hosp
- SUNY / Health Sciences Ctr at Stony Brook
- Nalle Clinic
- Univ Hosp of Cleveland / Case Western Reserve Univ
- Kaiser Permanente Med Ctr
- Univ TX San Antonio Health Science Ctr
- Saint Paul's Hosp
- Sunnybrook Health Science Ctr
- Toronto Gen Hosp
- Wellesley Hosp
- Hotel - Dieu de Montreal
- Saint Michael's Hosp