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OpenTrials
Completed

NCT Number: NCT00002025

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

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.

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Key information

Conditions

Cytomegalovirus Infections AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Amino Acid Metabolism, Inborn Errors Blood-Borne Infections Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytomegalovirus Retinitis DNA Virus Infections Eye Diseases Eye Infections Eye Infections, Viral Genetic Diseases, Inborn Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases Opportunistic Infections RNA Virus Infections Retinal Diseases Retinitis Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

3 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roche Global Development - Palo Alto

Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ganciclovir

Drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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