Cytopenias, HIV Infections
Conditions
Keywords
Neutropenia, Drug Interactions, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine
Brief summary
To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
Interventions
DRUGZidovudine
DRUGSargramostim
Sponsors
Sandoz
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Treatment: Allowed: * Minimal local irradiation for tumors. Patients must have: * Diagnosis of AIDS or AIDS related complex (ARC). * Neutropenia, due either to zidovudine (AZT) or HIV infection. * Life expectancy = or \> 6 months.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following: * Serum carotene less than 75 IU/ml. * Vitamin A level less than 75 IU/ml. * More than 4 foul-smelling or greasy stools per day. * Other criteria of malabsorption. * Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation. * Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection. Concurrent Medication: Excluded within 4 weeks of study entry: * Any investigational drug. * Immunomodulating agents. * Hormonal therapy. * Cytolytic chemotherapeutic agents. * Antiretroviral agent other than zidovudine (AZT). * Excluded within 4 months of study entry: * Suramin. * Excluded within 3 months of study entry: * Ribavirin. Patients with the following are excluded: * Significant malabsorption. * Tumor likely to require specific antitumor therapy during study. * Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions. * Uncorrected nutritional deficiencies that may contribute to neutropenia. * Hypersensitivity to zidovudine (AZT) or other nucleoside analogs. * Profound dementia or altered mental status that would prohibit the giving of informed consent. Prior Treatment: Excluded within 1 month of study entry: * Transfusion. * Excluded within 4 weeks of study entry: * Radiation therapy to greater than 100 cm2 body area. Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study. Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.
Countries
United States
Outcome results
None listed