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.
- Conditions
- HIV InfectionsCytopenias
- Registration Number
- NCT00002126
- Lead Sponsor
- Amgen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, 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
Wellesley Hosp
🇨🇦Toronto, Ontario, Canada
Toronto Gen Hosp
🇨🇦Toronto, Ontario, Canada
Hotel - Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Kaiser Permanente Med Ctr
🇺🇸Portland, Oregon, United States
TheraFirst Med Ctrs Inc
🇺🇸Fort Lauderdale, Florida, United States
Univ Hosp / Univ of Colorado Health Sci Ctr
🇺🇸Denver, Colorado, United States
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
Saint Michael's Hosp
🇨🇦Toronto, Canada
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
New England Deaconess Hosp
🇺🇸Boston, Massachusetts, United States
SUNY / Health Sciences Ctr at Stony Brook
🇺🇸Stony Brook, New York, United States
Sunnybrook Health Science Ctr
🇨🇦Toronto, Ontario, Canada
Nalle Clinic
🇺🇸Charlotte, North Carolina, United States
Univ TX San Antonio Health Science Ctr
🇺🇸San Antonio, Texas, United States
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
🇺🇸Birmingham, Alabama, United States
Maricopa County Med Ctr
🇺🇸Phoenix, Arizona, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States