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

Primary Purpose

Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring Retinitis, AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Roche Global Development - Palo Alto

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002025
Brief Title
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Official Title
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Study Type
Interventional

2. Study Status

Record Verification Date
September 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections, Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, AIDS-Related Opportunistic Infections, Immune Tolerance, Injections, Intravenous, Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Roche Global Development - Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States

12. IPD Sharing Statement

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

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