Overview

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.