Reduced mobilization of CD34+ stem cells in advanced human immunodeficiency virus type 1 disease.
R T Schooley, J Mladenovic, A Sevin...
https://pubmed.ncbi.nlm.nih.gov/10608761Completed
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID00001071
A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
24
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Stem Cells and Filgrastim
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
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:
- 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.
Exclusion Criteria
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:
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Status Unknown
2
University of Colorado Hospital CRS
Aurora, Colorado, United States
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
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.
T B Campbell, A Sevin, R W Coombs...
https://pubmed.ncbi.nlm.nih.gov/10607683