NCT00002009

Brief Summary

To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.

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

June 1, 1988

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:
  • Met the CDC criteria for the diagnosis of AIDS.
  • Total peripheral blood leukocyte count = or \< 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
  • Must have or have recovered from one or more opportunistic infection.
  • Serum antibody to HTLV-III/LAV with or without viremia.
  • Anticipated survival of at least 6 months.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • AIDS related complex (ARC).
  • History of malignancy other than Kaposi's sarcoma (KS).
  • 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 infections.
  • Presence of renal dysfunction.
  • Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.
  • Patients with the following are excluded:
  • AIDS related complex (ARC).
  • History of malignancy other than Kaposi's sarcoma (KS).
  • 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 an opportunistic infection.
  • Dementia or altered mental status that would prohibit the giving and understanding of informed consent.
  • Prior Medication:
  • +10 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

Related Publications (1)

  • Barbarini G, Garavelli G, Grisorio B, Barbaro G, Giangregorio F. GM-CSF in HIV related leukopenia: efficacy and tolerability of three months therapy on 50 patients. Int Conf AIDS. 1996 Jul 7-12;11(1):313 (abstract no TuB2279)

    BACKGROUND

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
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: 1988-06

Locations

US(2)