A Study of Stem Cells and Filgrastim

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

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.