Status:
COMPLETED
A Study of Stem Cells and Filgrastim
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 infecti...
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-p...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1998
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00001071
End Date
October 1 1998
Last Update
November 4 2021
Active Locations (2)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
2
University of Colorado Hospital CRS
Aurora, Colorado, United States