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

Roche

Status: Completed

Conditions: Cytomegalovirus Retinitis; HIV Infections; Cytomegalovirus Infections

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002025

029D

ICM 1691

Details and patient eligibility

About

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.

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.