Search / Trial NCT00001071

A Study of Stem Cells and Filgrastim

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

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Trial Information

Current as of December 08, 2024

Completed

Keywords

Granulocyte Colony Stimulating Factor Acquired Immunodeficiency Syndrome Aids Related Complex Stem Cells

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.

Trial Officials

Schooley R

Study Chair

Miles S

Study Chair

Pomerantz R

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

Aurora, Colorado, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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