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

Sponsor:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002025

Purpose

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

MedlinePlus related topics: Cytomegalovirus Infections HIV/AIDS

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002025

Locations

United States, California
Roche Global Development - Palo Alto
Palo Alto, California, United States, 94303

Sponsors and Collaborators

Hoffmann-La Roche

More Information

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 February 12, 2012