NCT00002008

Brief Summary

To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.

Trial Health

80
On Track

Trial Health Score

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

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

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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, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsCytopenias

Keywords

LeukopeniaDrug EvaluationGranulocyte-Macrophage Colony-Stimulating Factor

Interventions

SargramostimDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have:
  • Serum antibody to HIV with or without evidence of HIV.
  • Antigenemia.
  • Anticipated survival of at least 6 months.
  • Allowed:
  • Kaposi's sarcoma.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Malignancy other than Kaposi's sarcoma.
  • Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.
  • Primary hematologic or infectious disorders unrelated to AIDS virus infection.
  • Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
  • Patients with the following are excluded:
  • History of malignancy other than Kaposi's sarcoma.
  • Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.
  • Prior Medication:
  • Excluded within 3 weeks of study entry:
  • Marrow suppressive medication.
  • Excluded within 4 weeks of study entry:
  • Any investigational drug.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

Beth Israel Deaconess - West Campus

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

HIV InfectionsCytopeniaLeukopenia

Interventions

sargramostim

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 DiseasesLeukocyte Disorders

Study Design

Study Type
interventional
Phase
phase 1
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: 1989-01

Locations

US(2)