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

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.