Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

Study Overview
=================
Brief Summary
-----------------
To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.

Official Title
-----------------
Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

Conditions
-----------------
Cytomegalovirus Infections, HIV Infections

Intervention / Treatment
-----------------
* Drug: Ganciclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Topical acyclovir. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria. Transplant where a trial reduction of immunosuppressive drug treatment is not feasible. Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency. Neutropenia unless it is pre-existing. Thrombocytopenia unless it is pre-existing. Concurrent Medication: Excluded: Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs. Patients with the following are excluded: Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria. Transplant where a trial reduction of immunosuppressive drug treatment is not feasible. Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency. Neutropenia unless it is pre-existing. Thrombocytopenia unless it is pre-existing. Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ganciclovir|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ganciclovir, AIDS-Related Opportunistic Infections, Immune Tolerance, Drugs, Investigational, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome