A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

June 23, 2005 updated by: Sandoz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - West Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

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.

Exclusion Criteria

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:

Excluded:

  • Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
  • Excluded within 6 weeks of study entry:
  • Any investigational drug.

Prior Treatment:

Excluded within 6 weeks of study entry:

  • Systemic cytotoxic chemotherapy or irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

  • Regular, excessive use of alcohol, hallucinogens or agents which are addicting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 1988

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 067E
  • 101 (Hamilton Integrated Research Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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