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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.

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ClinicalTrials.gov Identifier: NCT00002126
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

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 Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
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






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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002126


  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, United States, 35294
United States, Arizona
Maricopa County Med Ctr
Phoenix, Arizona, United States, 85008
United States, California
CARE Ctr / UCLA Med Ctr
Los Angeles, California, United States, 90095
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Colorado
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, United States, 80262
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States, 33308
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 672143124
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699
United States, Massachusetts
New England Deaconess Hosp
Boston, Massachusetts, United States, 02215
United States, New York
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
Nalle Clinic
Charlotte, North Carolina, United States, 28207
United States, Ohio
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Oregon
Kaiser Permanente Med Ctr
Portland, Oregon, United States, 97227
United States, Texas
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
Canada, British Columbia
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Canada, Ontario
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Toronto Gen Hosp
Toronto, Ontario, Canada
Wellesley Hosp
Toronto, Ontario, Canada
Canada, Quebec
Hotel - Dieu de Montreal
Montreal, Quebec, Canada
Canada
Saint Michael's Hosp
Toronto, Canada
Sponsors and Collaborators
Amgen

ClinicalTrials.gov Identifier: NCT00002126     History of Changes
Other Study ID Numbers: 087A
GCSF-930101
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Neutropenia
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Neutropenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs