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

Exclusion Criteria

• •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.