A Study of Stem Cells and Filgrastim

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.

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.