An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Ganciclovir triphosphate

Criteria

Inclusion Criteria

Patients must have:

• AIDS.

• Stable CMV retinitis.

• Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days.

• No permanent central IV catheter at present.

• Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis.

• Consent of guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Require continuation of concomitant medications precluded by this protocol.

Concurrent Medication:

Excluded:

• Intravitreal anti-CMV treatment.

• Any other concomitant medications precluded by the protocol.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.