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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.

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Filgrastim
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Neutropenia, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Univ of Alabama at Birmingham / AIDS Outpatient Clinic
  • Maricopa County Med Ctr
  • CARE Ctr / UCLA Med Ctr
  • UCSF - San Francisco Gen Hosp
  • Univ Hosp / Univ of Colorado Health Sci Ctr
  • George Washington Univ Med Ctr
  • TheraFirst Med Ctrs Inc
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Univ of Kansas School of Medicine
  • Tulane Univ Med School
  • New England Deaconess Hosp
  • SUNY / Health Sciences Ctr at Stony Brook
  • Nalle Clinic
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Kaiser Permanente Med Ctr
  • Univ TX San Antonio Health Science Ctr
  • Saint Paul's Hosp
  • Sunnybrook Health Science Ctr
  • Toronto Gen Hosp
  • Wellesley Hosp
  • Hotel - Dieu de Montreal
  • Saint Michael's Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00002126
Brief 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.
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

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Amgen

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytopenias
Keywords
Neutropenia, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Filgrastim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Maricopa County Med Ctr
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
CARE Ctr / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Univ Hosp / Univ of Colorado Health Sci Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
672143124
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
New England Deaconess Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Gen Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Wellesley Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hotel - Dieu de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Saint Michael's Hosp
City
Toronto
Country
Canada

12. IPD Sharing Statement

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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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