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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002008
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1989

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002008 on ClinicalTrials.gov Archive Site
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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.

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Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Masking: 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.
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002008
067D, 106
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Sandoz Inc.
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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