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.

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00002126

Collaborator

(none)

250

Enrollment

Locations

11.4

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Infections Cytopenias	Drug: Filgrastim	Phase 2

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.

Study Design

Study Type:

Interventional

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham / AIDS Outpatient Clinic	Birmingham	Alabama	United States	35294
2	Maricopa County Med Ctr	Phoenix	Arizona	United States	85008
3	CARE Ctr / UCLA Med Ctr	Los Angeles	California	United States	90095
4	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
5	Univ Hosp / Univ of Colorado Health Sci Ctr	Denver	Colorado	United States	80262
6	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
7	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida	United States	33308
8	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
9	Univ of Kansas School of Medicine	Wichita	Kansas	United States	672143124
10	Tulane Univ Med School	New Orleans	Louisiana	United States	701122699
11	New England Deaconess Hosp	Boston	Massachusetts	United States	02215
12	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York	United States	11794
13	Nalle Clinic	Charlotte	North Carolina	United States	28207
14	Univ Hosp of Cleveland / Case Western Reserve Univ	Cleveland	Ohio	United States	44106
15	Kaiser Permanente Med Ctr	Portland	Oregon	United States	97227
16	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284
17	Saint Paul's Hosp	Vancouver	British Columbia	Canada
18	Sunnybrook Health Science Ctr	Toronto	Ontario	Canada
19	Toronto Gen Hosp	Toronto	Ontario	Canada
20	Wellesley Hosp	Toronto	Ontario	Canada
21	Hotel - Dieu de Montreal	Montreal	Quebec	Canada
22	Saint Michael's Hosp	Toronto		Canada