A Study of Stem Cells and Filgrastim

NCT ID: NCT00001071

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1998-10-31

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.

Conditions

HIV Infections

Keywords

Granulocyte Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Stem Cells

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Filgrastim

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Schooley R

Role: STUDY_CHAIR

Miles S

Role: STUDY_CHAIR

Pomerantz R

Role: STUDY_CHAIR

Locations

UCLA CARE Center CRS

Los Angeles, California, United States

University of Colorado Hospital CRS

Aurora, Colorado, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 10608761 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10607683 (View on PubMed)

Other Identifiers

11261

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 285

Identifier Type: -

Identifier Source: org_study_id