An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Erythropoietin, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Ganciclovir (DHPG) for treatment of CMV infections. Concurrent Treatment: Allowed: 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 area. Patients must have: AIDS or severe ARC. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Opportunistic infection requiring ongoing therapy with known bone marrow-suppressive agents. (Exception: 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. Concurrent Medication: Excluded: 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. Prior Medication: Excluded: 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. Prior Treatment: Excluded: 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.
Sites / Locations
- UCLA Med Ctr