A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.

Inclusion Criteria

Patients must have:

• Met the CDC criteria for the diagnosis of AIDS.
• Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
• Must have or have recovered from one or more opportunistic infection.
• Serum antibody to HTLV-III/LAV with or without viremia.
• Anticipated survival of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• AIDS related complex (ARC).
• History of malignancy other than Kaposi's sarcoma (KS).
• 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 infections.
• Presence of renal dysfunction.
• Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.

Patients with the following are excluded:

• AIDS related complex (ARC).
• History of malignancy other than Kaposi's sarcoma (KS).
• 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 an opportunistic infection.
• Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Prior Medication:

Excluded:

• Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
• Excluded within 6 weeks of study entry:
• Any investigational drug.

Prior Treatment:

Excluded within 6 weeks of study entry:

• Systemic cytotoxic chemotherapy or irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

• Regular, excessive use of alcohol, hallucinogens or agents which are addicting.