A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients With Cytopenia

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.