A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Inclusion Criteria Concurrent Treatment: Allowed: * Minimal local irradiation for tumors. Patients must have: * Diagnosis of AIDS or AIDS related complex (ARC). * Neutropenia, due either to zidovudine (AZT) or HIV infection. * Life expectancy = or \> 6 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following: * Serum carotene less than 75 IU/ml. * Vitamin A level less than 75 IU/ml. * More than 4 foul-smelling or greasy stools per day. * Other criteria of malabsorption. * Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation. * Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection. Concurrent Medication: Excluded within 4 weeks of study entry: * Any investigational drug. * Immunomodulating agents. * Hormonal therapy. * Cytolytic chemotherapeutic agents. * Antiretroviral agent other than zidovudine (AZT). * Excluded within 4 months of study entry: * Suramin. * Excluded within 3 months of study entry: * Ribavirin. Patients with the following are excluded: * Significant malabsorption. * Tumor likely to require specific antitumor therapy during study. * Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions. * Uncorrected nutritional deficiencies that may contribute to neutropenia. * Hypersensitivity to zidovudine (AZT) or other nucleoside analogs. * Profound dementia or altered mental status that would prohibit the giving of informed consent. Prior Treatment: Excluded within 1 month of study entry: * Transfusion. * Excluded within 4 weeks of study entry: * Radiation therapy to greater than 100 cm2 body area. Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study. Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.