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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate the patient's clinical response.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Ganciclovir triphosphate

Criteria

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.