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

Roche

Status: Completed

Conditions: HIV Infections; Cytomegalovirus Infections

Treatments: Drug: Ganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002024

029B

ICM 1257A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.