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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. Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on 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. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 research trials and 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. healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including 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.. 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 Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 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. Test subjects oftentimes recieve the best healthcare possible for their 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. condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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.  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.
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.
For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Amgen ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 250
Location and Contact Information:
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
United States
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 11794
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Wellesley Hosp
Toronto, Ontario,
Canada
Hotel - Dieu de Montreal
Montreal, Quebec,
Canada
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Kaiser Permanente Med Ctr
Portland, Oregon, 97227
United States
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Maricopa County Med Ctr
Phoenix, Arizona, 85008
United States
Nalle Clinic
Charlotte, North Carolina, 28207
United States
TheraFirst Med Ctrs Inc
Ft. Lauderdale, Florida, 33308
United States
Saint Michael's Hosp
Toronto, ,
Canada
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
United States
Sunnybrook Health Science Ctr
Toronto, Ontario,
Canada
Toronto Gen Hosp
Toronto, Ontario,
Canada
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Additional Information:
Study ID Numbers: 087A; GCSF-930101
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002126
Other Cytopenias Studies:
1. A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
2. A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
3. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
4. 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.
5. Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC
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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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