An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

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Sandoz

Status and phase

Completed
Phase 1

Conditions

Cytopenias
HIV Infections

Treatments

Drug: Sargramostim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002008
106
067D

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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