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. - Full Text View

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

MedlinePlus related topics:

AIDS

Drug Information available for:

Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor

U.S. FDA Resources

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

250

Detailed Description:

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002126

Show 22 Study Locations

Sponsors and Collaborators

Amgen

More Information

Study ID Numbers:	087A, GCSF-930101
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002126
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Neutropenia

Granulocyte Colony-Stimulating Factor

Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Hematologic Diseases

Acquired Immunodeficiency Syndrome

Agranulocytosis

Leukocyte Disorders

Granulocytopenia

Immunologic Deficiency Syndromes

Virus Diseases

Neutropenia

HIV Infections

Sexually Transmitted Diseases

Leukopenia

Retroviridae Infections

Additional relevant MeSH terms:

Communicable Diseases

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Amgen
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002126