Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Completed · Not applicable
Conditions studied: Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002025
- Run by
- Hoffmann-La Roche
- Last updated by the study team
- 2005-06-24
Who can join
Age: 0 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Roche Global Development - Palo Alto — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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