Cytopenias, HIV Infections
Conditions
Keywords
Pilot Projects, Neutropenia, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine
Brief summary
To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. 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
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Zidovudine (AZT) on NIAID 86-C-175. Patients must have: * Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex. * Granulocytopenia (\< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175. * Life expectancy \> 3 months. * Functioning indwelling central venous access device in place. Prior Medication: Allowed within 48 hours of study entry: * Prophylactic antibiotics.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Critically ill or clinically unstable. * Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry. * Ongoing IV alimentation. * Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia. * Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection. * Malignancy likely to require systemic treatment during study. Patients with the following are excluded: * Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions. * Hypersensitivity to zidovudine (AZT) or any other nucleoside analog. Prior Medication: Excluded within 48 hours of study entry: * Antibiotics. * Excluded within 30 days of study entry: * Antiretroviral agents other than zidovudine (AZT). * Acyclovir. * Ganciclovir. * Any investigational drug. * Immunomodulating drugs. * Cytolytic chemotherapeutic agents. * Corticosteroids. * Immunoglobulin preparations. * Excluded within 4 months of study entry: * Suramin. Prior Treatment: Excluded within 6 months of study entry: * Bone marrow transplantation. * Excluded within 4 weeks of study entry: * Lymphocyte transfusions. * Radiation therapy.
Countries
United States
Outcome results
None listed