To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage
colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in
HIV-infected children who have developed granulocytopenia as a result of continuous
intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of
concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic
benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated
infectious complications.
Inclusion Criteria
Concurrent Medication:
Allowed:
- Zidovudine (AZT) on NIAID 86-C-175.
Patients must have:
- Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
- Granulocytopenia (< or = to 800 cells/mm3) associated with the administration of AZT
on protocol NIAID 86-C-175.
- Life expectancy > 3 months.
- Functioning indwelling central venous access device in place.
Prior Medication:
Allowed within 48 hours of study entry:
- Prophylactic antibiotics.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Critically ill or clinically unstable.
- Significant, active opportunistic or other infection requiring specific drug therapy
at time of study entry.
- Ongoing IV alimentation.
- Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
- Past history of or current evidence for any chronic hematologic disorder other than
hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
- Malignancy likely to require systemic treatment during study.
Patients with the following are excluded:
- Critically ill, clinically unstable, or with concomitant diseases listed in Patient
Exclusion Co-existing Conditions.
- Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.
Prior Medication:
Excluded within 48 hours of study entry:
- Antibiotics.
- Excluded within 30 days of study entry:
- Antiretroviral agents other than zidovudine (AZT).
- Acyclovir.
- Ganciclovir.
- Any investigational drug.
- Immunomodulating drugs.
- Cytolytic chemotherapeutic agents.
- Corticosteroids.
- Immunoglobulin preparations.
- Excluded within 4 months of study entry:
- Suramin.
Prior Treatment:
Excluded within 6 months of study entry:
- Bone marrow transplantation.
- Excluded within 4 weeks of study entry:
- Lymphocyte transfusions.
- Radiation therapy.
