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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

Schering-Plough
ClinicalTrials.gov · Datasets · License: Public Domain
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acquired-immunodeficiency-syndromecombinationdrug-therapyhiv-infectionsneutropenia
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.
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