Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.