NCT00002070

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Schering-Plough · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Retinitis
• HIV Infections

Interventions

Type	Name	Description
DRUG	Sargramostim
DRUG	Ganciclovir

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

14 sites across 1 country: United States