Search / Trial NCT00002025

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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Retinitis Aids Related Opportunistic Infections Immune Tolerance Injections, Intravenous Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

Description

No description provided

Gender

ALL

Eligibility 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.

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Palo Alto, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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