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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Gender

ALL

Eligibility 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.