To assess the safety and efficacy of subcutaneously administered sargramostim (
granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the
neutrophil count in HIV-infected adults who have developed neutropenia as a result of
receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of
subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in
HIV-infected adults with pre-existing neutropenia who are at high risk of developing
hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time.
To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural
history of HIV infection and associated infectious complications.
- 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.
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.
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:
- Excluded within 3 months of study entry:
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
- 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
Excluded within 1 month of study entry:
- 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.