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

Study Overview
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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.

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

Conditions
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Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
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* Drug: Ganciclovir


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ganciclovir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinitis, AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome