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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infections Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Roche Global Development - Palo Alto

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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ICM 1691

Identifier Type: -

Identifier Source: secondary_id

029D