HIV InfectionsNCT00001071
A Study of Stem Cells and Filgrastim
A study testing Filgrastim in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Filgrastim
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Oct 1998
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- PCP prophylaxis.
- Antiretroviral therapy in patients with CD4 counts <= 500 cells/mm3.
- Narcotic analgesics for grade 3/4 bone pain toxicity.
- Patients must have:
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- HIV infection.
- HIV infected patients with CD4 count > 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count < 200 cells/mm3 may or may not have AIDS-defining conditions.
- No antiretroviral therapy within the past 30 days in patients with asymptomatic disease and CD4 count > 500 cells/mm3.
- Stable antiretroviral therapy for the past 60 days if CD4 count <= 500 cells/mm3.
- Suitable venous access.
- Prior Medication:
- Allowed:
- Prior antiretroviral therapy.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Current malignancy.
- Any medication condition that interferes with study evaluation.
- Known hypersensitivity to E. coli-derived proteins (e.g., insulin, human growth hormones).
- Concurrent Medication:
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- Excluded:
- Acute treatment for serious opportunistic infection.
- Systemic cytotoxic chemotherapy.
- Concurrent Treatment:
- Excluded:
- Systemic radiation therapy.
- Patients with the following prior conditions are excluded:
- Prior malignancy.
- Leukapheresis or lymphopheresis within the past 180 days.
- Significant active CNS disease or seizures within the past year.
- Prior Medication:
- Excluded:
- G-CSF or GM-CSF within the past 6 months.
- Investigational antiretrovirals within the past 30 days.
- Treatment for opportunistic infection within the past 14 days.
- Active alcohol or substance abuse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Hospital CRS
Aurora, Colorado
UCLA CARE Center CRS
Los Angeles, California, 90095
About this study
Official title: A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
To determine the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure.
Read the detailed description
Patients and volunteers receive seven daily subcutaneous injections of G-CSF. On days 5 and 6 of drug administration, patients have peripheral blood mononuclear cells harvested by leukapheresis. HIV-positive patients are stratified into three cohorts based on CD4 count and presence of symptoms. If no increase in number of harvested stem cells and no grade 4 bone pain toxicity occur in two of the first three patients in a cohort, then the last three patients in that cohort will receive a dose escalation. Patients are followed for 24 weeks.
- Conditions
- HIV Infections
- Being tested
- Filgrastim
- Keywords
- Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stem Cells
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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)
- Study completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Schooley R, Study chairMiles S, Study chairPomerantz R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001071
- Sponsor's protocol ID
- ACTG 285
- Other IDs
- 11261
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Schooley R, Mladenovil J, Campbell T, Pomerantz R, Miles S, Wong R, Landay A. ACTG 285: G-CSF (Filgrastim) for mobilization of CD34+ cells from the bone marrow of HIV-1 infected persons. Int Conf AIDS. 1998;12:838 (abstract no 42323)
Schooley RT, Mladenovic J, Sevin A, Chiu S, Miles SA, Pomerantz RJ, Campbell TB, Bell D, Ambruso D, Wong R, Landay A, Coombs RW, Fox L, Kamoun M, Jacovini J. Reduced mobilization of CD34+ stem cells in advanced human immunodeficiency virus type 1 disease. J Infect Dis. 2000 Jan;181(1):148-57. doi: 10.1086/315168.
PubMed 10608761Campbell TB, Sevin A, Coombs RW, Peterson GC, Rosandich M, Kuritzkes DR, Mladenovic J, Landay A, Wong R, Ambruso D, Miles S, Pomerantz RJ, Schooley RT. Changes in human immunodeficiency virus type 1 virus load during mobilization and harvesting of hemopoietic progenitor cells. Adult AIDS Clinical Trials Group 285 Study Team. Blood. 2000 Jan 1;95(1):48-55.
PubMed 10607683
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
- ClinicalTrials.gov ID
- NCT00001071
- Acronym / sponsor ID
- ACTG 285
- Conditions
- HIV Infections
- Keywords
- Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stem Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 1998 (actual)
- 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 the safety of stem cell harvesting after administration of filgrastim ( G-CSF ) to mobilize bone marrow stem cells into the peripheral blood in patients at various stages of HIV-1 infection as well as in HIV-negative volunteers. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure.
Detailed description
Patients and volunteers receive seven daily subcutaneous injections of G-CSF. On days 5 and 6 of drug administration, patients have peripheral blood mononuclear cells harvested by leukapheresis. HIV-positive patients are stratified into three cohorts based on CD4 count and presence of symptoms. If no increase in number of harvested stem cells and no grade 4 bone pain toxicity occur in two of the first three patients in a cohort, then the last three patients in that cohort will receive a dose escalation. Patients are followed for 24 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- PCP prophylaxis.
- Antiretroviral therapy in patients with CD4 counts <= 500 cells/mm3.
- Narcotic analgesics for grade 3/4 bone pain toxicity.
- HIV infection.
- HIV infected patients with CD4 count > 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count < 200 cells/mm3 may or may not have AIDS-defining conditions.
Key exclusion criteria (22 listed)
- Current malignancy.
- Any medication condition that interferes with study evaluation.
- Known hypersensitivity to E. coli-derived proteins (e.g., insulin, human growth hormones).
- Acute treatment for serious opportunistic infection.
- Systemic cytotoxic chemotherapy.
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 4 Nov 2021.
- BackgroundSchooley R, Mladenovil J, Campbell T, Pomerantz R, Miles S, Wong R, Landay A. ACTG 285: G-CSF (Filgrastim) for mobilization of CD34+ cells from the bone marrow of HIV-1 infected persons. Int Conf AIDS. 1998;12:838 (abstract no 42323)
- Background: PubMed 10608761Schooley RT, Mladenovic J, Sevin A, Chiu S, Miles SA, Pomerantz RJ, Campbell TB, Bell D, Ambruso D, Wong R, Landay A, Coombs RW, Fox L, Kamoun M, Jacovini J. Reduced mobilization of CD34+ stem cells in advanced human immunodeficiency virus type 1 disease. J Infect Dis. 2000 Jan;181(1):148-57. doi: 10.1086/315168.
- Background: PubMed 10607683Campbell TB, Sevin A, Coombs RW, Peterson GC, Rosandich M, Kuritzkes DR, Mladenovic J, Landay A, Wong R, Ambruso D, Miles S, Pomerantz RJ, Schooley RT. Changes in human immunodeficiency virus type 1 virus load during mobilization and harvesting of hemopoietic progenitor cells. Adult AIDS Clinical Trials Group 285 Study Team. Blood. 2000 Jan 1;95(1):48-55.
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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.
Schooley R study chair
Miles S study chair
Pomerantz R study chair
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filgrastim in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 14 inclusion and 22 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
On the ClinicalTrials.gov record for NCT00001071, which also lists 3 linked publications.
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 4 Nov 2021.