Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

You may not be if

• Co-existing Condition:
• Patients with the following are excluded:
• Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
• Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
• Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
• Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
• Hypersensitivity to acyclovir or ganciclovir.
• Receiving antimetabolite treatment that cannot be discontinued.
• Concurrent Medication:
• Excluded:
• Antimetabolites.
• Alkylating agents.
• Nucleoside analogs (topical ophthalmics are permitted).
• Interferon.
• Foscarnet.
• Cytokines.
• Patients with the following are excluded:
• Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
• Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
• Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
• Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
• Hypersensitivity to acyclovir or ganciclovir.
• Receiving antimetabolite treatment that cannot be discontinued.
• Patients must qualify as follows:
• Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study.
• Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection.
• Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease.