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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002126
• Other study ID #: 087A
• Secondary ID: GCSF-930101
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cytopenias
• HIV Infections
• Infection
• Neutropenia

Intervention

Drug:
• Filgrastim

Locations

Country	Name	City	State
Canada	Hotel - Dieu de Montreal	Montreal	Quebec
Canada	Saint Michael's Hosp	Toronto
Canada	Sunnybrook Health Science Ctr	Toronto	Ontario
Canada	Toronto Gen Hosp	Toronto	Ontario
Canada	Wellesley Hosp	Toronto	Ontario
Canada	Saint Paul's Hosp	Vancouver	British Columbia
United States	Univ of Alabama at Birmingham / AIDS Outpatient Clinic	Birmingham	Alabama
United States	New England Deaconess Hosp	Boston	Massachusetts
United States	Nalle Clinic	Charlotte	North Carolina
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ Hosp of Cleveland / Case Western Reserve Univ	Cleveland	Ohio
United States	Univ Hosp / Univ of Colorado Health Sci Ctr	Denver	Colorado
United States	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida
United States	CARE Ctr / UCLA Med Ctr	Los Angeles	California
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Maricopa County Med Ctr	Phoenix	Arizona
United States	Kaiser Permanente Med Ctr	Portland	Oregon
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,