Cytopenias, HIV Infections
Conditions
Keywords
Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor
Brief summary
To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.
Interventions
DRUGSargramostim
Sponsors
Sandoz
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Patients must have: * Serum antibody to HIV with or without evidence of HIV. * Antigenemia. * Anticipated survival of at least 6 months. * Allowed: * Kaposi's sarcoma.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Malignancy other than Kaposi's sarcoma. * Excessive diarrhea (more than 5 liquid or non-liquid stools per day). * Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection. * Primary hematologic or infectious disorders unrelated to AIDS virus infection. * Dementia or altered mental status that would prohibit the giving and understanding of informed consent. Patients with the following are excluded: * History of malignancy other than Kaposi's sarcoma. * Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection. Prior Medication: Excluded within 3 weeks of study entry: * Marrow suppressive medication. * Excluded within 4 weeks of study entry: * Any investigational drug. Prior Treatment: Excluded within 4 weeks of study entry: * Systemic cytotoxic chemotherapy. * Irradiation. Risk Behavior: Excluded within 3 months of study entry: * Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.
Countries
United States
Outcome results
None listed