A Study of Stem Cells and Filgrastim
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001071
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 24
- Expected to finish
- 1998-10-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCLA CARE Center CRS — Los Angeles, California, United States
- University of Colorado Hospital CRS — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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