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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002008
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

November 2, 1999
August 31, 2001
June 24, 2005
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No Changes Posted
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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
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
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.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • Cytopenias
Drug: Sargramostim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002008
067D
106
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Sandoz
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NIH AIDS Clinical Trials Information Service
January 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP