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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Page 1 of 1 (2 locations)

1

UCLA CARE Center CRS

Los Angeles, California, United States, 90095

2

University of Colorado Hospital CRS

Aurora, Colorado, United States