Clinical trial NCT00002126: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Cytopenias
Keywords: Neutropenia
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 250
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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.

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