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An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Sandoz Inc.
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002008
  Purpose

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.


Condition Intervention Phase
HIV Infections
Cytopenias
Drug: Sargramostim
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
Official Title: An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Systemic cytotoxic chemotherapy.
  • Irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

  • Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002008

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
United States, Massachusetts
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Sandoz Inc.
  More Information

No publications provided

Study ID Numbers: 067D, 106
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002008     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Leukopenia
Drug Evaluation
Granulocyte-Macrophage Colony-Stimulating Factor

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Hematologic Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Leukocyte Disorders
Leukopenia
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Hematologic Diseases
Acquired Immunodeficiency Syndrome
Leukocyte Disorders
Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Leukopenia
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009