Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002025
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1989
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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.
Condition | Intervention |
---|---|
Cytomegalovirus Infections Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Masking: Open Label Primary Purpose: Treatment |
Official Title: | Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Ganciclovir sodium
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130312224458im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 3 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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![](https://webarchive.library.unt.edu/web/20130312224458im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002025 History of Changes |
Other Study ID Numbers: | 029D, ICM 1691 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis AIDS-Related Opportunistic Infections Immune Tolerance Injections, Intravenous |
Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Infections Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Retinal Diseases Eye Diseases Eye Infections, Viral Eye Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013