A Study of Stem Cells and Filgrastim

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001071
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 23, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Filgrastim Not Applicable

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-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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
Actual Study Completion Date : October 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


  • Acute treatment for serious opportunistic infection.
  • Systemic cytotoxic chemotherapy.

Concurrent Treatment:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001071

United States, California
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Schooley R
Study Chair: Miles S
Study Chair: Pomerantz R

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001071     History of Changes
Other Study ID Numbers: ACTG 285
11261 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Stem Cells

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs