Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Recombinant Proteins, Retinitis, AIDS-Related Opportunistic Infections, Neutropenia, Ganciclovir, Drug Therapy, Combination, Granulocyte-Macrophage Colony-Stimulating Factor, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Brief summary
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
Interventions
DRUGSargramostim
DRUGGanciclovir
Sponsors
Schering-Plough
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient must have the following: * AIDS as defined by CDC criteria. * Retinitis as diagnosed by the study ophthalmologist. * Performance status 0, 1, or 2. * Ability to give informed consent and suitability of intravenous access for scheduled blood tests. * Patient may have Kaposi's sarcoma or basal skin cancer.
Exclusion criteria
Co-existing Condition: Patients with the following are excluded: * Active acute infection requiring treatment. * Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy. * Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer. Patients with the following are excluded: * Active acute infection requiring treatment. * Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy. * Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer. Prior Medication: Excluded: * Granulocyte macrophage colony-stimulating factor (GM-CSF). * Colony stimulating factor. * Interleukin 3. * Excluded within 7 days of study entry: * Zidovudine (AZT). * Trimethoprim / sulfamethoxazole (TMP / SMX). * Pyrimethamine. * Excluded within 30 days of study entry: * Biologic response modifiers. * Cytotoxic agents. * Investigational agents. Prior Treatment: Excluded: * Radiation therapy. Required within 1 week of study entry: * One or more doses of ganciclovir.
Countries
United States
Outcome results
None listed