Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
Retinitis, AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
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.
Interventions
DRUGGanciclovir
Sponsors
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed