A Study of Stem Cells and Filgrastim (NCT00001071) | Clinical Trial Compass
CompletedNot Applicable
A Study of Stem Cells and Filgrastim
United States24 participants
Plain-language 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. To determine the surface phenotypic and functional characteristics as well as the viral load in the stem cells obtained following this procedure.
Who can participate
Age range18 Years
SexALL
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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.
…
Trial details
NCT IDNCT00001071
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)