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.
Purpose
