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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001071 |
Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Filgrastim |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim |
| Estimated Enrollment: | 24 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Active alcohol or substance abuse.
Contacts and Locations| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Pennsylvania | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| Study Chair: | Schooley R | |
| Study Chair: | Miles S | |
| Study Chair: | Pomerantz R |
More Information
| Study ID Numbers: | ACTG 285 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00001071 History of Changes |
| Health Authority: | United States: Federal Government |
|
Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome AIDS-Related Complex Stem Cells |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |