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

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.