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A Study of Stem Cells and Filgrastim

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Filgrastim
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stem Cells

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCLA CARE Center CRS
  • University of Colorado Hospital CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001071
Brief Title
A Study of Stem Cells and Filgrastim
Official Title
A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Filgrastim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Schooley R
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Miles S
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pomerantz R
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Schooley R, Mladenovil J, Campbell T, Pomerantz R, Miles S, Wong R, Landay A. ACTG 285: G-CSF (Filgrastim) for mobilization of CD34+ cells from the bone marrow of HIV-1 infected persons. Int Conf AIDS. 1998;12:838 (abstract no 42323)
Results Reference
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PubMed Identifier
10608761
Citation
Schooley RT, Mladenovic J, Sevin A, Chiu S, Miles SA, Pomerantz RJ, Campbell TB, Bell D, Ambruso D, Wong R, Landay A, Coombs RW, Fox L, Kamoun M, Jacovini J. Reduced mobilization of CD34+ stem cells in advanced human immunodeficiency virus type 1 disease. J Infect Dis. 2000 Jan;181(1):148-57. doi: 10.1086/315168.
Results Reference
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PubMed Identifier
10607683
Citation
Campbell TB, Sevin A, Coombs RW, Peterson GC, Rosandich M, Kuritzkes DR, Mladenovic J, Landay A, Wong R, Ambruso D, Miles S, Pomerantz RJ, Schooley RT. Changes in human immunodeficiency virus type 1 virus load during mobilization and harvesting of hemopoietic progenitor cells. Adult AIDS Clinical Trials Group 285 Study Team. Blood. 2000 Jan 1;95(1):48-55.
Results Reference
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A Study of Stem Cells and Filgrastim

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