To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte
colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and
concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe
AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of
EPO given 3 times weekly by SC injection concomitantly with G-CSF and prior to and
concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and
tolerance of 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly
treated with G-CSF and EPO. To study the effect of G-CSF alone and in combination with EPO
on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia
and semiquantitative HIV cocultures.
- 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
Patients must have:
- A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC
- Life expectancy > 6 months.
- Defined blood cell counts that may be achieved by transfusion.
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
- 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.
- Trimethoprim / sulfamethoxazole.
- Non-FDA approved antiretrovirals.
- Hyperimmunization with polio virus.
- Dextran sulfate.
- Fu zheng herbs.
- AL 721 or its congeners.
- 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
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.
- Colony stimulating factors.
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.
Excluded within 3 months of study entry:
- Regular excessive use of alcohol, hallucinogens or other psychotropic agents which
are possibly addicting.