A Study of Stem Cells and Filgrastim
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ClinicalTrials.gov Identifier: NCT00001071 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 23, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Filgrastim | Not Applicable |
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 |


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

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 ClinicalTrials.gov identifier (NCT number): NCT00001071
United States, California | |
UCLA CARE Center CRS | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States |
Study Chair: | Schooley R | ||
Study Chair: | Miles S | ||
Study Chair: | Pomerantz R |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov 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 Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |