NCT00001071

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Granulocyte Colony-Stimulating FactorAcquired Immunodeficiency SyndromeAIDS-Related ComplexStem Cells

Interventions

FilgrastimDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, United States

Location

Related Publications (3)

  • 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)

    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.

    PMID: 10608761BACKGROUND

  • 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.

    PMID: 10607683BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Schooley R

    STUDY CHAIR

  • Miles S

    STUDY CHAIR

  • Pomerantz R

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 1998

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(2)