NCT00002281

Brief Summary

To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV cocultures.

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

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

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

June 24, 2005

Status Verified

January 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsCytopenias

Keywords

Injections, SubcutaneousErythropoietinAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudine

Interventions

FilgrastimDRUG
Epoetin alfaDRUG
ZidovudineDRUG

Eligibility Criteria

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

You may qualify if:

  • Concurrent Treatment:
  • Allowed:
  • Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.
  • Patients must have:
  • A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines.
  • Life expectancy \> 6 months.
  • Defined blood cell counts that may be achieved by transfusion.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • History of malignancy other than Kaposi's sarcoma (KS).
  • Presence of \> 50 cutaneous KS lesions or progression of KS over the previous 30 days.
  • Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents.
  • History of cardiovascular disease.
  • History of seizures.
  • HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent.
  • Presence of iron deficiency anemia as defined by serum ferritin \< 30 ng or iron to TIBC ratio \< 15 percent.
  • A PT \> 15 and a PTT \> 40 unless due to a documented circulating lupus anticoagulant.
  • Concurrent Medication:
  • Excluded:
  • Trimethoprim / sulfamethoxazole.
  • Fansidar.
  • Non-FDA approved antiretrovirals.
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Med Ctr

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Miles SA, Mitsuyasu RT, Moreno J, Baldwin G, Alton NK, Souza L, Glaspy JA. Combined therapy with recombinant granulocyte colony-stimulating factor and erythropoietin decreases hematologic toxicity from zidovudine. Blood. 1991 May 15;77(10):2109-17.

    PMID: 1709368BACKGROUND

MeSH Terms

Conditions

HIV InfectionsCytopeniaAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

FilgrastimEpoetin AlfaZidovudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsErythropoietinThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-01

Locations

US(1)