A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
HIV Infections, Cytopenias
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
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.
Sites / Locations
- UCLA Med Ctr