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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: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| 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
Show 22 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002126 History of Changes |
| Other Study ID Numbers: | 087A, GCSF-930101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Neutropenia Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome |
|
HIV Infections Acquired Immunodeficiency Syndrome Neutropenia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |