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

Launched by AMGEN · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

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.