To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant
granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to
and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or
severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO
given three times weekly by subcutaneous 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 three dose levels of AZT given concomitantly with G-CSF and EPO in patients
with AIDS or severe ARC. To study the effects of G-CSF on neutrophil function and number in
patients with AIDS or severe ARC. 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.
- Ganciclovir (DHPG) for treatment of CMV infections.
- 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
Patients must have:
AIDS or severe ARC.
Patients with the following symptoms or conditions are excluded:
- Opportunistic infection requiring ongoing therapy with known bone marrow-suppressive
- 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.
- 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.
- 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.
- 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.