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

Completed · Phase 1

Conditions studied: HIV Infections, Cytopenias

In brief

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.

Key facts

Study ID

NCT00002008

Run by

Sandoz

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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