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| Sponsor: | Amgen |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002126 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Cytopenias |
Drug: Filgrastim |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 250 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded:
Substance abuse that would compromise compliance.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham / AIDS Outpatient Clinic | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Maricopa County Med Ctr | |
| Phoenix, Arizona, United States, 85008 | |
| United States, California | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| CARE Ctr / UCLA Med Ctr | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Univ Hosp / Univ of Colorado Health Sci Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| George Washington Univ Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| TheraFirst Med Ctrs Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 672143124 | |
| United States, Louisiana | |
| Tulane Univ Med School | |
| New Orleans, Louisiana, United States, 701122699 | |
| United States, Massachusetts | |
| New England Deaconess Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Nalle Clinic | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Ohio | |
| Univ Hosp of Cleveland / Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Kaiser Permanente Med Ctr | |
| Portland, Oregon, United States, 97227 | |
| United States, Texas | |
| Univ TX San Antonio Health Science Ctr | |
| San Antonio, Texas, United States, 78284 | |
| Canada | |
| Saint Michael's Hosp | |
| Toronto, Canada | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Sunnybrook Health Science Ctr | |
| Toronto, Ontario, Canada | |
| Toronto Gen Hosp | |
| Toronto, Ontario, Canada | |
| Wellesley Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Hotel - Dieu de Montreal | |
| Montreal, Quebec, Canada | |
More Information
| Study ID Numbers: | 087A, GCSF-930101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002126 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neutropenia Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Hematologic Diseases Acquired Immunodeficiency Syndrome Agranulocytosis Leukocyte Disorders |
Infection Immunologic Deficiency Syndromes Virus Diseases Neutropenia HIV Infections Sexually Transmitted Diseases Lentivirus Infections Leukopenia Retroviridae Infections |