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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002025
• Other study ID #: 029D
• Secondary ID: ICM 1691
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: September 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• Cytomegalovirus Retinitis
• HIV Infections
• Infection
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
United States	Roche Global Development - Palo Alto	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States,