A Study of Stem Cells and Filgrastim

• Status: Completed
• Trial end date: 1998-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Lenograstim

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.