An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)

Inclusion criteria

Concurrent Medication:

Allowed:

• Ganciclovir (DHPG) for treatment of CMV infections.

Concurrent Treatment:

Allowed:

• Radiotherapy or laser therapy for Kaposi's sarcoma lesions provided dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm total body surface area.

Patients must have:

AIDS or severe ARC.

Exclusion criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Opportunistic infection requiring ongoing therapy with known bone marrow-suppressive agents. (Exception:
• patients may take ganciclovir for treatment of CMV infections.)
• Evidence of a primary hematologic or infectious disorder unrelated to infection with the HIV virus.
• HIV-related dementia or altered mental status that would prohibit informed consent.
• More than 50 cutaneous Kaposi's sarcoma lesions or progression of Kaposi's sarcoma during the previous 30 days.
• Uncontrolled hypertension (defined as diastolic greater than 100 mm Hg).
• Presence of iron deficiency anemia as defined by serum ferritin less than 30 ng or iron TIBC ration less than 15 percent.

Concurrent Medication:

Excluded:

• Known bone marrow-suppressive agents such as trimethoprim / sulfamethoxazole or Fansidar for PCP prophylaxis.
• Any other non-FDA approved agent that may have antiretroviral activity.
• Hyperimmunization with polio virus, ribavirin, isoprinosine, dextran sulfate, fu zheng herbs, AL 721 or its congeners, imuthiol, interferons, chronic (> 10 days out of 30 days) use of Zovirax (acyclovir), and/or > 3 g/day oral vitamin C.

Patients with the following prior conditions are excluded:

• History of malignancy other than Kaposi's sarcoma.
• History of cardiovascular disease or seizures.

Prior Medication:

Excluded:

• Systemic cytotoxic chemotherapy within the previous 4 weeks for Kaposi's sarcoma.
• Investigational drugs within the previous 4 weeks.
• Prior colony stimulating factor (CSF).
• Any non-FDA approved drug within the previous 2 weeks.

Prior Treatment:

Excluded:

• Radiotherapy within the previous 4 weeks for Kaposi's sarcoma. Regular excessive use, currently or within the previous 3 months, of alcohol or hallucinogens or other psychotropic agents that are possibly addictive.