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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Official Title ^ICMJE	Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label
Condition ^ICMJE	Cytomegalovirus Infections Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Ganciclovir
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	3 Months and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002025
Responsible Party
Study ID Numbers ^ICMJE	029D, ICM 1691
Study Sponsor ^ICMJE	Hoffmann-La Roche
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	September 1989
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP