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Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient Clinical research trials and Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient clinical trial. Test subjects typically obtain the finest healthcare available for their Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient  Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
For Condition: Cytomegalovirus Infections,Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 3 Months/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment:
Location and Contact Information:
Roche Global Development - Palo Alto
Palo Alto, California, 94303
United States
Additional Information:
Study ID Numbers: 029D; ICM 1691
Study Start Date:
Record last reviewed: September 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002025
Other Cytomegalovirus Infections Studies:
1. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
2. A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
3. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS Who Cannot Use Ganciclovir
4. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
5. Longitudinal Study of Ocular Complications of AIDS (LSOCA)
Related Studies:
Other Cytomegalovirus Infections Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
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