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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00002025

Collaborator

(none)

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infections Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir	N/A

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.