A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex

Inclusion Criteria

Concurrent Treatment:

Allowed:

• Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.

Patients must have:

• A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines.
• Life expectancy > 6 months.
• Defined blood cell counts that may be achieved by transfusion.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• History of malignancy other than Kaposi's sarcoma (KS).
• Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days.
• Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents.
• History of cardiovascular disease.
• History of seizures.
• HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent.
• Presence of iron deficiency anemia as defined by serum ferritin < 30 ng or iron to TIBC ratio < 15 percent.
• A PT > 15 and a PTT > 40 unless due to a documented circulating lupus anticoagulant.

Concurrent Medication:

Excluded:

• Trimethoprim / sulfamethoxazole.
• Fansidar.
• Non-FDA approved antiretrovirals.
• Hyperimmunization with polio virus.
• Ribavirin.
• Isoprinosine.
• Dextran sulfate.
• Fu zheng herbs.
• AL 721 or its congeners.
• Imuthiol.
• Interferons.
• Chronic use of acyclovir (> 10 days out of 30 days).
• = or > 3g/day oral vitamin C.

Patients with the following are excluded:

• Co-existing conditions and symptoms described in Patient Exclusion Co-existing Conditions.

Prior Medication:

Excluded within 2 weeks of study entry:

• Any non-FDA approved drug.
• Excluded within 4 weeks of study entry:
• Systemic cytotoxic chemotherapy for Kaposi's sarcoma.
• Investigational agents.
• Excluded:
• Colony stimulating factors.

Prior Treatment:

Excluded within 4 weeks of study entry:

• Radiation therapy for Kaposi's sarcoma exceeding 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.

Risk Behavior:

Excluded within 3 months of study entry:

• Regular excessive use of alcohol, hallucinogens or other psychotropic agents which are possibly addicting.