HIV InfectionsPhase 2NCT00002126
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 Phase 2 study testing Filgrastim in people with HIV Infections and Cytopenias, run by Amgen at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Filgrastim
- How many people
- 250 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States16 sites
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294
New England Deaconess Hosp
Boston, Massachusetts, 02215
Nalle Clinic
Charlotte, North Carolina, 28207
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Maricopa County Med Ctr
Phoenix, Arizona, 85008
Kaiser Permanente Med Ctr
Portland, Oregon, 97227
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 11794
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Canada6 sites
Hotel - Dieu de Montreal
Montreal, Quebec
Sunnybrook Health Science Ctr
Toronto, Ontario
Toronto Gen Hosp
Toronto, Ontario
Wellesley Hosp
Toronto, Ontario
Saint Michael's Hosp
Toronto
Saint Paul's Hosp
Vancouver, British Columbia
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Filgrastim
- Keywords
- Neutropenia, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome
- Medical subject headings
- HIV Infections, Cytopenia, Neutropenia, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002126
- Sponsor's protocol ID
- 087A
- Other IDs
- GCSF-930101
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002126
- Acronym / sponsor ID
- 087A
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Neutropenia, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- 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.
Key exclusion criteria (9 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filgrastim | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim in people with HIV Infections and Cytopenias, run by Amgen at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.