Inclusion Criteria
Patients must have:
- HIV seropositivity by Western blot.
- Advanced ARC or AIDS as defined by CDC.
- Cytopenia defined as total peripheral leukocyte count of < 3,000 cells/mm3 or platelet count of < 100,000 cells/mm3 or serum hemoglobin < 10 g/dl.
- Anticipated life expectancy = or > 6 months.
- Ambulatory.
- Willing to sign informed consent.
- Willing to forego use of any other investigational therapies except ddI.
Prior Medication:
Allowed > 2 weeks prior to study entry:
- zidovudine.
- Allowed > 4 weeks prior to study entry:
- systemic cytotoxic chemotherapy; investigational drugs; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
- Allowed > 6 weeks prior to study entry:
- other hemopoietic growth factor treatment as GM-CSF, EPO.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Active opportunistic infection.
- Symptoms of CNS disease referable to HIV infection.
- Dementia or altered mental status that would prohibit giving and understanding informed consent.
Systemic chemotherapy.
- Investigational therapies other than ddI.
- Medications with known myelosuppressive effects such as ganciclovir, trimethoprim/sulfamethoxazole or dapsone or AZT.
- Other hematopoietic growth factor treatments as GM-CSF, G-CSF, or EPO.
Prophylactic therapy for pneumocystis or oral thrush.
- ddI.
- Corticosteroids or topical corticosteroid creams.
Patients may not have:
- Life expectancy < 6 months.
- Active drug or alcohol abuse.
- Active opportunistic infections.
- Treatment with any other investigational drugs except ddI within 4 weeks of study entry.
- Dementia or altered mental state that prohibits giving informed consent.
- Symptoms of CNS disease referable to HIV infection.
- Major surgery within 4 weeks of study entry.
- History of major pulmonary or cardiac disease.
- History of any prior malignancy other than Kaposi's sarcoma or noninvasive subcutaneous carcinoma.
- Documented allergic disorder such as asthma, history of anaphylaxis, atopy, serum sickness, or bronchospasm.
Not allowed within 2 weeks prior to study entry:
- zidovudine (AZT).
- Not allowed within 4 weeks prior to study entry:
- systemic cytotoxic chemotherapy; investigational drugs other than ddI; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
- Not allowed within 6 weeks prior to study entry:
- other hematopoietic growth factor treatment as GM-CSC, G-CSF, EPO.
Radiation therapy or major surgery within 4 weeks of study entry.
Active drug or alcohol abuse.
Purpose
